The successful candidate will be responsible for conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.

Key responsibilities include:

• Conducting on-site and remote monitoring of clinical research studies
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing defined components of projects or processes within the area of responsibility
• Ensuring accurate and timely documentation of monitoring activities and findings
• Collaborating with cross-functional teams to support clinical trial operations

The ideal candidate will have:

• A Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Preferred certifications include:

• Certified Clinical Research Associate (CCRA) or equivalent certification

Necessary skills include:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate

Qualifications:

• Native Bulgarian language and English proficiency
• Bachelor's Degree in scientific discipline or health care preferred
• At least 1 year of on-site monitoring experience
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Job Data by YubHub.

As a Senior Clinical Research Associate (CRA) at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities:

• Monitor clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conduct site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborate with cross-functional teams to ensure timely and accurate data collection and reporting.
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Build and maintain effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

• Advanced degree in a relevant field such as life sciences, nursing, or medicine.
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Ability to travel at least 60% of the time (international and domestic) and possess a valid driver's license.

Rewards & Benefits:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Job Data by YubHub.

Responsibilities:

• Assist CRAs and RSU team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF)
• Prepare, handle, distribute, file, and archive clinical documentation and reports
• Review study files for completeness
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies
• Track and manage Case Report Forms (CRFs), queries and clinical data flow
• Act as a central contact for the clinical team for designated project communications
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training

Qualifications:

• Bachelor's Degree Required
• 3 years administrative support experience
• Equivalent combination of education, training and experience
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of applicable protocol requirements

The potential base pay range for this role, when annualized, is $35,800.00 - $123,000.00.

Job Data by YubHub.

Key Responsibilities:

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements, customer requirements, and internal policies
• Meet project recruitment targets and develop effective recruitment strategies
• Contribute to project risk mitigation plans and manage clinical risks throughout the project's lifecycle
• Ensure clinical quality delivery by identifying quality standards, monitoring compliance, and managing quality issues
• Manage clinical aspects of project finances, including Estimate at Completion (EAC)
• Identify and manage clinical stakeholders, both internal and external
• Collaborate with the clinical team to achieve milestones and report to stakeholders as needed
• Resource and talent planning for the clinical team, including guidance and training
• Conduct regular team meetings and communicate effectively to achieve objectives
• Support professional development by providing feedback to clinical team line managers
• May contribute to developing clinical delivery strategies for proposals and participate in bid defense preparations
• May mentor and coach new peers and attend site visits as applicable

Requirements:

• Bachelor's degree in healthcare or a scientific discipline
• 5 years of clinical research or monitoring experience, or equivalent combination of education, training, and experience
• Basic knowledge of project management practices and terminology
• Good knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Broad protocol knowledge and therapeutic knowledge
• Understanding of project finances and clinical trials
• Strong written and verbal communication skills, including good command of English
• Problem-solving, planning, time management, and prioritization skills
• Leadership, influencing, and negotiation skills
• Good software and computer skills, including Microsoft Office applications
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Ability to work across geographies and display high awareness of cultural differences

What We Offer:

• Competitive salary: $93,100.00 - $232,800.00 per year
• Incentive plans, bonuses, and other forms of compensation may be offered
• A range of health and welfare benefits

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Oncology and Phase I experience
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Fluent German and English
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

Responsibilities:

• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Collaborate with sites to adapt, drive, and track subject recruitment plans
• Provide protocol and related study training to assigned sites and establish regular communication lines
• Evaluate study site practices and escalate quality issues as needed
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
• Maintain site documents and verify Investigator's Site File in accordance with GCP and local regulatory requirements
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans
• Collaborate with study team members for project execution support

Qualifications:

• Bachelor's degree in a scientific discipline or healthcare preferred
• At least 1 year of on-site monitoring experience
• Knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines)
• Good therapeutic and protocol knowledge
• Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad
• Excellent written and verbal communication skills, including good command of English
• Organizational, problem-solving, and time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Fluent German and English
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

Responsibilities:

• Conduct site monitoring visits in accordance with contracted scope of work and Good Clinical Practice
• Collaborate with sites to adapt, drive, and track subject recruitment plans
• Provide protocol and related study training to assigned sites and establish regular lines of communication
• Evaluate the quality and integrity of study site practices and escalate quality issues as needed
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify Investigator's Site File (ISF) maintenance
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans
• Collaborate with study team members for project execution support

Qualifications:

• High School Diploma or equivalent Degree in scientific discipline or health care preferred
• At least 2 years of on-site monitoring experience
• Good knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable)
• Strong written and verbal communication skills, including good command of English language
• Organizational and problem-solving skills, and effective time and financial management skills

Job Data by YubHub.

As a Senior Clinical Research Associate (CRA) at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

• Advanced degree in a relevant field such as life sciences, nursing, or medicine.
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Ability to travel at least 60% of the time (international and domestic) and possess a valid driver’s license.

Rewards & Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Job Data by YubHub.

As a CRA II, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. You will review study protocols, informed consent forms, and case report forms.

Key responsibilities include:

• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing defined components of projects or processes within the area of responsibility
• Ensuring accurate and timely documentation of monitoring activities and findings
• Collaborating with cross-functional teams to support clinical trial operations

Requirements:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Preferred certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification

Necessary skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a Sr CRA, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. You will develop tools, procedures, and processes to ensure quality monitoring, and contribute to the design, implementation, and delivery of processes, programs, and policies.

Key responsibilities include:

• Conducting on-site and remote monitoring of clinical research studies
• Developing monitoring plans, checklists, and standard operating procedures
• Providing expert input and feedback during development and review stages
• Directing the work of lower-level professionals and managing processes and programs
• Ensuring trials are conducted in accordance with regulatory requirements and company standards
• Providing guidance and support to clinical research teams
• Maintaining accurate and timely documentation of monitoring activities
• Identifying and resolving issues related to clinical trial conduct
• Collaborating with cross-functional teams to ensure successful trial execution

Requirements:

• Bachelor's degree in a related field
• Minimum of 5 years of experience in clinical research monitoring
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Preferred certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification

Necessary skills:

• Proficiency in clinical trial management systems and software
• Ability to manage multiple projects and priorities
• Strong attention to detail and organizational skills
• Ability to travel as required for on-site monitoring
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a CRAII/ Sr CRAI, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.

Key responsibilities include:

• Conducting on-site and remote monitoring of clinical research studies
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing defined components of projects or processes within the area of responsibility
• Ensuring accurate and timely documentation of monitoring activities and findings
• Collaborating with cross-functional teams to support clinical trial operations

Requirements:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Preferred certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification

Necessary skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

The role involves conducting on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. The successful candidate will develop and implement tools, procedures, and processes to ensure quality monitoring, contribute to the design, implementation, and delivery of processes, programs, and policies, and manage defined components of projects or processes within the area of responsibility.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a CRA I/II, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices. You will review study protocols, informed consent forms, and case report forms, and develop and implement tools, procedures, and processes to ensure quality monitoring.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

This is a local trial management support position, responsible for clinical delivery in Argentina.

Essential Functions

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC).
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements.
• Resourcing and Talent Planning of the clinical team.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.

Qualifications

• Bachelor's Degree in health care or other scientific discipline required.
• Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Fluency in the local country language (spoken and written) and advanced English is required.
• Based in Buenos Aires, Argentina.
• Requires basic knowledge of Project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Job Data by YubHub.

The Director of US Portfolio Delivery (“US Local Delivery Lead Director”) provides leadership, oversight and local US delivery of studies in support of global R&D programs. The LDL-Director is accountable for a portfolio of assets, and manages the activities of US Program Leads (PLs) and US Local Delivery Leads (LDLs) to ensure the delivery of clinical studies to the required quality standards, GSK written standards and ICH GCP.

Key Responsibilities:

• Lead a team of LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and number of US studies conducted. Provide training, coaching, mentoring, line and performance management.
• Responsible for effectively managing capacity utilization of LDL ensuring alignment of capabilities with study requirements, resource availability and business priorities.
• Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and best practice.
• Accountable for ensuring the completion of all deliverables for studies within assigned portfolio to agreed timelines, budget and quality standards.
• Responsible for identifying and sharing best practices, standardizing across the US and representing local/regional clinical operations on global and cross functional initiatives.
• Recruits and develops LDLs. Evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans for direct reports.
• Partners with local and central teams to ensure robust study feasibility with reference to study complexity, clinical facilities and monitoring resource.
• Establishes and manages key strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed as necessary.
• Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.
• Assists with audits/inspections of local clinical operations department & study / sites in the country, as required.
• Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities.
• Leads or participates in regional/global clinical operations projects (as appropriate).
• Available and willing to travel as job requires.

Basic Qualifications:

• University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area
• At least 10 years of experience in clinical operations delivery within the pharmaceutical or biotech industry, including leadership of complex, multi‑site clinical studies in the US.
• At least 5 years of experience leading and developing clinical operations leaders or managers (e.g., LDLs, study managers, CTMs) in a high‑volume, high‑complexity environment.
• Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements, including risk identification, issue escalation, and problem resolution.
• Strong working knowledge of ICH‑GCP, GSK written standards, and US regulatory expectations.

Preferred Qualifications:

• Experience leading delivery across late phase and/or registrational cardiovascular, vaccines and/or steatotic liver disease studies is highly valued.
• Experience leading delivery of a portfolio of studies across multiple asset teams.
• Experience delivering clinical trials in the US, including studies with large site networks, complex protocols, and competitive enrollment environments.

The US annual base salary for new hires in this position ranges from $153,750 to $256,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Job Data by YubHub.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Responsibilities

• Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Supporting the development of a subject recruitment plan
• Establishing regular lines of communication plus administering protocol and related study training to assigned sites
• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

Qualifications

• Minimum of a Bachelor's Degree in a scientific discipline or healthcare
• Experience of 1 year in on-site monitoring clinical trials
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of Polish and English language
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients

The potential base pay range for this role, when annualized, is 132,800.00 zł - 280,000.00 zł.

Job Data by YubHub.

Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics.

May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources.

Essential Functions

• Perform assigned complex administrative tasks to support team members with project execution
• Assist in updating and maintaining complex data in systems within project timelines and per project plans
• Monitor filing accuracy and compliance to IQVIA or customer file plans and Standard Operating Procedures (SOPs)
• Train team members on records management tasks, policies, and procedures
• Establish and maintain effective internal and external client communications
• Design and administer records management systems and processes
• Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs
• Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects
• May function as team leader for records management projects.

Qualifications

• Bachelor's Degree Records management or related field
• 3-4 years experience working in a Records Management technically-related area. Equivalent combination of education, training and experience
• Strong knowledge of applicable research and regulatory requirements, i.e., International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines
• Knowledge of technology applications relevant to records management environments
• General knowledge of computer technology and software programs, and accurate data entry skills
• Ability to perceive and analyze problems, develop solutions, and make sound decisions
• Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
• Attention to detail and accuracy in work
• Ability to remain focused with regards to details under pressure
• Strong organizational, planning, and decision making skills
• Excellent oral and written communication skills, including good command of English language
• Ability to establish and maintain effective working relationships with internal and external clients
• Ability to lead others

Job Data by YubHub.

Responsibilities:

• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Collaborate with sites to adapt, drive, and track subject recruitment plans in line with project needs
• Provide protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage study progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans
• Collaborate with study team members for project execution support as needed

Qualifications:

• Minimum of 1 year of independent on-site monitoring experience as a Clinical Research Associate (CRA)
• Bachelor's Degree in a scientific discipline or healthcare preferred
• Equivalent combination of education, training, and experience may be accepted in lieu of degree
• Good knowledge of and skill in applying applicable clinical research regulatory requirements, including GCP and ICH guidelines
• Good therapeutic and protocol knowledge as provided in company training
• Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable)
• Excellent written and verbal communication skills, including good command of English language
• Strong organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Benefits: The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job Data by YubHub.

As a Clinical Research Associate II, you will perform site monitoring visits, work with sites to adapt and drive subject recruitment plans, administer protocol and related study training, evaluate study site practices, manage study progress, ensure site documents are available, and create and maintain documentation.

Responsibilities:

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Evaluate the quality and integrity of study site practices
• Manage the progress of assigned studies
• Ensure copies/originals site documents are available for filing in the Trial Master File
• Create and maintain documentation regarding site management and monitoring visit findings

Requirements:

• University degree in a scientific discipline or healthcare
• Minimum of 18 months of independent, on-site monitoring experience as a CRA
• Excellent communication skills in Dutch, French, and English
• Good knowledge of and skill in applying applicable clinical research regulatory requirements
• Exceptional interpersonal and cross-cultural communication skills
• Collaborative mindset to work effectively with cross-functional global teams

Benefits:

• Grow your career with access to development resources, training, and advancement opportunities
• Enjoy flexibility and trust to balance professional and personal commitments
• Expand your therapeutic knowledge through dedicated learning and development programs
• Be part of a successful global organization with an excellent reputation and supportive culture
• Benefit from a company car, mobile phone, and an attractive rewards and benefits package

For candidates able to start before December 2026, a discretionary sign-on bonus of up to 4,300 EUR may be offered.

Job Data by YubHub.

This role involves performing site monitoring visits, working with sites to adapt and drive subject recruitment plans, administering protocol and related study training, evaluating study site practices, managing study progress, ensuring site documents are available, and creating documentation regarding site management.

Responsibilities:

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Evaluate the quality and integrity of study site practices
• Manage the progress of assigned studies
• Ensure copies/originals site documents are available for filing in the Trial Master File
• Create and maintain documentation regarding site management
• Collaborate and liaise with study team members for project execution support

Profile:

• University degree in scientific discipline or health care
• Minimum of 3 years of independent, on-site monitoring experience as a CRA
• Excellent communication skills in Dutch, French, and English
• Good knowledge of applicable clinical research regulatory requirements
• Exceptional interpersonal and cross-cultural communication skills
• Collaborative mindset to work effectively with cross-functional global teams

Benefits:

• Grow your career with access to development resources, training, and advancement opportunities
• Enjoy flexibility and trust to balance professional and personal commitments
• Expand therapeutic knowledge through dedicated learning and development programs
• Be part of a successful global organization with an excellent reputation and supportive culture
• Benefit from a company car, mobile phone, and attractive rewards and benefits package

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Requirements:

• Bachelor's Degree in scientific discipline or health care preferred
• Prior on-site monitoring experience; or equivalent combination of education, training and experience
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Job Data by YubHub.

Key Responsibilities:

• Conduct site visits to monitor clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP).
• Serve as the primary point of contact for investigational sites to ensure smooth study operations.
• Review and verify the accuracy of clinical data collected from study sites through Source Document Verification (SDV).
• Provide ongoing training to site staff on study protocols and regulatory requirements.
• Prepare monitoring reports, maintain study records, and contribute to overall trial documentation.

Qualifications:

• Life Sciences university degree or certification in a related allied health profession from an accredited institution.
• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Knowledge of monitoring procedures and the clinical trial process.
• At least 3 years of independent monitoring experience.
• Fluency in Romanian and English, both written and verbal.

What We Offer:

• Flexible work arrangements, including hybrid and remote options.
• Career growth opportunities in a supportive environment.
• Dedicated Line Manager.
• Opportunity to work directly with a leading sponsor on innovative studies.
• Attractive salary and Fortrea benefits.

Job Data by YubHub.

As a CRA, you will perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Your Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

Your Profile:

• University degree in scientific discipline or health care
• 2+ years of experience as a CRA
• Very good computer skills including MS Office
• Excellent command of Dutch, French and English language
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license class B

What You Can Expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Excellent working environment in a stable, international, reputable company
• Company car, mobile phone and attractive benefits packaging

Job Data by YubHub.

We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits,selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1.5 years of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

The potential base pay range for this role, when annualized, is $90,200.00 - $175,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job Data by YubHub.

Essential Functions

• Ensure project timelines are met and facilitate the orderly transfer, imaging, scanning, retention, and disposition of project-related and business records.
• Ensure all work is conducted in accordance with SOPs, policies, practices, Good Clinical Practice (GCP), and applicable regulatory requirements, and meets quality and timeline metrics.
• Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destinations within agreed timelines.
• Monitor filing accuracy and compliance with IQVIA or customer file plans and Standard Operating Procedures (SOPs).
• Conduct and manage imaging and scanning processes, and train staff on applicable imaging and scanning procedures.
• Maintain records center security to protect record integrity by ensuring compliance with SOPs.
• Interface with internal departments to support retrieval projects and ensure information needs are met.
• Train team members on records management tasks, policies, and procedures.
• Serve as the primary point of contact for internal and external clients.
• Coordinate the transfer, recall, and disposition of records to commercial records storage centers.
• Oversee the disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment.
• Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
• May function as team leader for records management projects.

Qualifications

• Bachelor’s degree in Records Management or a related field, or equivalent combination of education, training, and experience.
• Minimum of four (4) years of experience working in a technically related records management environment.
• Prior experience with Trial Master File (TMF) oversight, review and/or reconciliation across clinical studies
• Strong knowledge of applicable research and regulatory requirements, including International Council for Harmonization (ICH), Good Clinical Practice (GCP), and relevant local laws, regulations, and guidelines.
• Working knowledge of technology applications relevant to records management environments.
• Ability to identify and analyze problems, develop effective solutions, and make sound decisions.
• Demonstrated ability to manage multiple tasks and projects within defined timelines while balancing competing priorities.
• Strong attention to detail and ability to remain focused under pressure.
• Excellent organizational, planning, and decision-making skills.
• Strong written and verbal communication skills, including a solid command of the English language.
• Ability to establish and maintain effective working relationships with internal and external clients.
• Demonstrated ability to lead and guide others.

Job Data by YubHub.

Responsibilities:

• Plan, assign, and direct work, assess performance, and guide professional development
• Participate in the selection and interviewing process for new employees
• Ensure that staff have the necessary resources and training to complete job responsibilities
• Manage the quality of assigned staff's clinical work through regular review and evaluation
• Identify quality risks and issues and create corrective action plans
• Collaborate with other clinical teams and functional leadership to manage project-related challenges

Qualifications:

• Bachelor's Degree in a scientific discipline or healthcare preferred
• Prior clinical trial experience in a management/leadership capacity
• In-depth knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines)
• Good leadership, organisational, and problem-solving skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Excellent written and verbal communication skills in English

Job Data by YubHub.

Essential Functions

• Manage staff in accordance with organisation's policies and applicable regulations, including planning, assigning, and directing work, assessing performance, and guiding professional development.
• Participate in the selection and onboarding of new employees.
• Ensure staff have the necessary materials, systems access, and training to complete job responsibilities.
• Allocate resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
• Manage the quality of assigned staff's clinical work through regular review and evaluation.
• Identify quality risks and issues and create corrective action plans.
• Ensure staff meet defined workload and quality metrics.
• Collaborate with other clinical teams and functional leadership to manage project-related challenges.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare.
• Prior clinical trial experience, including experience in a management/leadership capacity.
• In-depth knowledge of applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Good leadership skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Excellent written and verbal communication skills.
• Strong organisational and problem-solving skills.
• Effective time management skills and ability to manage competing priorities.

Job Data by YubHub.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
• Work with experienced clinical staff.
• Perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Ensure the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
• May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Prior 2 years clinical oncology experience mandatory.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Knowledge of applicable protocol requirements as provided in company training.
• Be flexible with the ability to travel nationwide.
• Flexible working hours in an hybrid or home-based role in Paris, Lyon, Marseille.

Job Data by YubHub.

We currently offer the exciting opportunity to join the sponsor dedicated team as experienced Clinical Trials Assistant (m/w/d) in full-time and work in a mixture of office-based in Vienna and in home-office.

Responsibilities

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files and completeness.
• Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.
• May serve as subject matter expert for business processes.
• May lead Clinical Trial Coordinators study teams.
• May participate in departmental quality or process improvement initiatives.
• May occasionally accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Required Knowledge, Skills and Experience

• Bachelor’s or higher-level degree preferable in life science or High School Diploma and apprenticeship in life science, the medical or pharmaceutical field or office management.
• 2-4 years of administrative support experience in clinical research, e.g. as Clinical Trials Assistant, Project Assistant, inhouseCRA, Study Start-Up Assistant.
• Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Fluent languages skills in German on at least C1 level and good command of English.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Effective communication, organizational and planning skills.
• Ability to work independently and to effectively prioritize tasks while working on multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Flexibility to visit our client's office within the Vienna region on a regular basis.

Monthly gross salary: starting at 3.000 EUR basic - an overpay according to skills and working experience is possible.

Job Data by YubHub.

Essential Functions

• Manage staff in accordance with organisation’s policies and applicable regulations, including planning, assigning, and directing work, assessing performance, guiding professional development, rewarding and disciplining employees, and addressing employee relations issues.
• Participate in selecting and hiring new employees, ensuring proper onboarding and training.
• Ensure staff have necessary materials, systems access, and training to complete job responsibilities, and provide oversight for training plans and SOP reviews.
• Allocate resources to clinical research projects by assigning staff based on experience and training.
• Manage the quality of staff's clinical work through regular review and evaluation.
• Identify quality risks and issues, creating corrective action plans as needed.
• Ensure staff meet defined workload and quality metrics through regular review and reporting.
• Collaborate with other clinical teams and functional leadership to manage project challenges and achieve customer service goals.
• Participate in organisational quality or process improvement initiatives.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare preferred.
• Prior clinical trial experience, including management or leadership capacity, or equivalent combination of education, training, and experience.
• In-depth knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
• Good leadership, communication, organisational, and problem-solving skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Command of English.
• Ability to establish and maintain effective working relationships.

Job Data by YubHub.

Essential Functions:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Some organizations require completion of CRA training program or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Job Data by YubHub.

As a Trainee Clinical Research Associate / Associate CRA (m/w/d), you'll work across innovative studies and therapeutic areas, build your reputation with leading pharmaceutical and biotechnology partners, and grow your skills through structured training, mentorship, and genuine global career pathways.

Key Responsibilities:

• Complete therapeutic area, protocol-specific, and clinical research training required to perform assigned responsibilities.
• Gain practical experience in study conduct and site management through collaboration with experienced clinical research professionals.
• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.
• Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.
• Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.
• Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.
• Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.
• Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications.
• Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution.
• Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.

What you'll bring:

• University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.
• Completed advanced training in clinical research with 2-6 month duration is mandatory.
• Good knowledge of clinical trial processes, Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
• Excellent communication, organizational, and stakeholder management skills.
• Fluent written and verbal communication skills in German language (minimum C1 level), along with a strong command of English.
• Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.
• Willingness to travel within the assigned region (up to 40-60% of working time). A valid Class B driver's license.
• Home-office location throughout Germany (preference is North-Rhin-Westphalia, the Hamburg area, or the Frankfurt area).
• Availability to start on 16.Nov. or 1.Dec. 2026 is mandatory.

What you can expect:

• Permanent employment contract.
• In-depth training on the job, mentoring and co-monitoring.
• Home-Office in Germany and flexible working schedule.
• Company car or car allowance, accident insurance and more.

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred
• Requires at least 1 year of on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted in lieu of degree
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Job Data by YubHub.

Your responsibilities will include:

• Performing site selection, initiation, monitoring, and close-out visits
• Supporting the development of a subject recruitment plan
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborating with experts on study sites and client representatives

Qualifications:

• University degree in life science or other scientific discipline, or apprenticeship in healthcare
• Minimum of one year of on-site monitoring experience, or alternatively, minimum one year of experience as Study Coordinator/CTC, etc.
• Knowledge of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong written and verbal communication skills, attention to detail, and ability to work in a fast-paced environment
• Fluent command of German and English
• Flexibility to business travel up to 60% of working time
• Driver's license class B

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences
• Home-office, company car/car allowance, accident insurance, pension, and more

Job Data by YubHub.

In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations.

Key Responsibilities

• Conduct all types of site visits,selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

Job Data by YubHub.

Responsibilities:

• Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
• Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines
• Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination
• Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation
• Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders
• Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
• Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
• Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
• Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability

Qualifications:

• Bachelor's degree in a related field (e.g., life sciences, clinical research)
• Minimum of 3 years of experience in clinical trial management or a related field
• In-depth knowledge of clinical research processes and regulations
• Strong project management and organizational skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in using clinical trial management software and tools

Certifications:

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills:

• Strong analytical and problem-solving skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Job Data by YubHub.

You will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients.

Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development. With access to world-class training and mentoring, you'll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Your responsibilities will include:

• Performing site selection, initiation, monitoring and close-out visits.
• Supporting the development of a subject recruitment plan.
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
• Collaborating with experts at study sites and with client representatives.
• Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).
• Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.

Qualifications:

• University Degree in life science or other scientific discipline or apprenticeship in the health care field.
• Minimum of 12 months of on-site monitoring experience.
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment.
• Fluency in German on at least C1 level and a good command of English.
• Flexibility to travel up to 40-60% of working time.
• Driver's license class B.

What you can expect:

• Permanent contract.
• Home-office and flexible working schedules.
• Competitive salary.
• Company car or car allowance, accident insurance, pension and more.
• Resources that promote your career growth.
• Dynamic work environments that expose you to new experiences.

Job Data by YubHub.

Responsibilities:

• Manage customer deliverables for assigned projects and bring continuity to project design and delivery through customer delivery
• Provide tactical, day-to-day customer-facing leadership at project level, including project planning, defining project/scope management, quality management, and project financial management
• Act as an account owner over a program or customer portfolio and report program/portfolio level metrics
• Perform role of solution architect responsible for crafting and defending proposed solutions to new standalone Safety business opportunities
• Represent as Safety SME and provide leadership and accountability for customer-facing collateral and operational support
• Manage finances for assigned projects, update financial systems, and work closely with manager on revenue recognition, invoicing, and project financial analysis
• Develop specialist expertise and act as a Subject Matter Expert (SME) on departmental or global initiatives
• Support start-up of new projects using standard operating procedures and best practices
• Attend meetings with internal and external stakeholders, provide project status updates, and define processes
• Work with Sales and Proposals to ensure rapid, seamless, tailored responses to opportunities
• Participate in sales activities, sales presentations, and proposal development
• Contribute during client and internal audits and inspections for assigned projects
• Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans
• Work closely with Lifecycle Safety management to address problem areas and customer needs

Qualifications:

• Bachelor's Degree in Health science or other directly related field
• 2-3 years' experience of Lifecycle Safety (Pharmacovigilance, CEVA, Medical Information, safety Publishing, Risk Management etc) with project management experience
• Knowledge of applicable global, regional and local clinical research regulatory requirements
• Strong prioritization, planning, and organizational skills
• Effective verbal and written communication skills
• Ability to work independently and manage competing priorities
• Strong presentation skills and report writing skills
• Accountability, ownership, and transparency
• Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills

Job Data by YubHub.

Oncology & Global Experience Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams ensuring projects meet delivery requirements at all times.

Essential Functions

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
• Conduct regular team meetings and communicate appropriately to achieve objectives.
• Support professional development by providing feedback to clinical team line managers on performance relative to project tasks.
• May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
• May mentor and coach new peers as they assimilate into this role.
• May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• May attend site visits as applicable in support of project delivery.

Qualifications

• Bachelor's Degree in health care or other scientific discipline required
• Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Requires basic knowledge of Project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires broad protocol knowledge and therapeutic knowledge.
• Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
• Requires understanding of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Communication - Strong written and verbal communication skills including good command of English language.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work delivery and output.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Effective communication - Ability to influence without authority.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

Job Data by YubHub.

Key responsibilities include:

• Taking a leading role in preparing assigned documents, including confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, and communicating directly with the customer
• Managing day-to-day workload, identifying project needs, tracking timelines, and implementing customer requests
• Leading customer meetings independently and delivering basic level training to small groups or individuals within IQVIA
• Providing guidance to more junior colleagues and proposing revisions to standard operating procedures (SOPs) or suggesting process improvements for consideration
• Completing project finance activities, including monitoring and forecasting budgeted hours

Requirements:

• Bachelor's Degree in life sciences related discipline or related field
• Typically requires at least 3 years of prior relevant experience and related competency levels
• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents
• Ability to identify deficiencies, errors, and inconsistencies in a protocol or report
• Good understanding of common statistical methods used in clinical trials and/or interpretation of their results
• Excellent written and oral communication skills, including grammatical/technical writing skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

The potential base pay range for this role, when annualized, is $71,900.00 - $182,000.00.

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

Responsibilities:

• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Collaborate with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Provide protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP/ICH and local regulatory requirements.
• Create and maintain documentation regarding site management, monitoring visit findings and action plans.
• Collaborate with study team members for project execution support as needed.

Qualifications:

• Master's Degree in Life Sciences.
• CRA certification according to Ministerial requirements.
• Completion of CRA training program or prior monitoring experience.
• Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable).
• Excellent written and verbal communication skills, including good command of English language.
• Strong organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

The potential base pay range for this role, when annualized, is €33,900.00 - €61,700.00.

Job Data by YubHub.

The role involves conducting standardized clinical interviews and psychiatric assessments with study participants, ensuring protocol compliance, data quality, and consistency across all evaluations.

Responsibilities:

• Conduct protocol-required remote clinical interviews and assessments with study participants.
• Administer and score study-specific psychiatric rating scales and structured interviews according to sponsor and protocol requirements.
• Maintain consistency and reliability across all participant assessments.
• Participate in study training, calibration, standardization, and certification activities as required.
• Review participant history and relevant documentation prior to assessments.
• Complete assessments, documentation, and data entry within required timelines.
• Ensure compliance with Good Clinical Practice (GCP), study protocols, and applicable regulations.
• Collaborate with clinical teams and study stakeholders to support data quality and participant safety.
• Attend project meetings and ongoing quality review sessions when required.

Requirements:

• Master's degree (MA/MS) in Psychology, Counseling, Psychiatric Nursing, Social Work, or a related clinical discipline.
• PhD, PsyD, MD, DO, or equivalent advanced clinical qualification preferred.
• Minimum 2 years of clinical experience with PTSD populations.
• Minimum 2 years of experience administering CAPS-5 and/or other structured psychiatric interviews.
• Strong understanding of PTSD diagnosis, symptomatology, and treatment.
• Demonstrated competency administering structured clinical interviews and rating scales.
• Excellent verbal and written communication skills.
• Strong attention to detail and commitment to assessment quality and consistency.
• Effective organizational and time-management skills.
• Ability to work independently in a remote environment.
• Proficiency with Microsoft Office applications and web-based clinical platforms.
• Native-level proficiency in German and fluency in English.

Preferred qualifications:

• CAPS-5 Certification (all four certificates preferred).
• Experience administering psychiatric assessments within clinical research trials.
• Experience with CNS and/or psychiatric clinical studies.
• Experience conducting remote or centralized assessments.
• Familiarity with PTSD outcome measures and structured diagnostic interviews.
• Previous experience serving as an independent rater, interviewer, or clinical trial assessor.

Job Data by YubHub.

Responsibilities:

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans)
• Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project's lifecycle
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues

Requirements:

• Bachelor's Degree in Healthcare or other scientific discipline
• Requires 8 years of clinical research/monitoring experience or equivalent combination of education, training and experience
• Minimum 3 years of regional/global trial management experience in the pharmaceutical industry or CRO
• In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Knowledge of project finances and clinical trials
• Cell Therapy/Hematology TA experience is an advantage

Job Data by YubHub.

Essential Functions:

• Conduct site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Collaborate with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
• Provide protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, escalating quality issues as needed
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain documentation regarding site management, monitoring visit findings, and action plans
• Collaborate with study team members for project execution support as necessary

Qualifications:

• Bachelor's degree in a scientific discipline or healthcare preferred
• At least 1 year of on-site monitoring experience
• Equivalent combination of education, training, and experience may be accepted in lieu of degree
• Good knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint
• Written and verbal communication skills, including good command of English language
• Organizational and problem-solving skills, effective time and financial management skills, and ability to establish and maintain effective working relationships

Job Data by YubHub.

Responsibilities:

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF), to track site compliance and performance within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
• Conduct periodic reviews of study files for completeness.
• Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications:

• Bachelor's degree and above.
• Equivalent combination of education, training, and experience.
• Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organisational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.

Requirements:

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 3 years of on-site monitoring experience.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

What We Offer:

• Competitive salary
• Opportunities for professional growth and development
• Collaborative and dynamic work environment

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.

Qualifications:

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 1.5 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

The potential base pay range for this role, when annualized, is $87,200.00 - $182,000.00.

Job Data by YubHub.

We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits,selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1.5 years of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

The potential base pay range for this role, when annualized, is $87,200.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Job Data by YubHub.

The ideal candidate will have a minimum of 6 months of hands-on experience in oncology studies and will play a key role in ensuring the successful execution of clinical trials in compliance with applicable regulations and sponsor requirements.

Key Responsibilities

• Perform monitoring and site management activities to ensure that clinical trial sites conduct studies and report data in accordance with the study protocol, applicable regulations, and sponsor requirements.
• Conduct site monitoring visits including site selection, initiation, routine monitoring, and close-out visits in line with contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Work closely with sites to adapt, drive, and track subject recruitment plans to support project timelines and predictability.
• Deliver protocol, study-specific, and ongoing training to investigative sites and maintain regular communication to manage expectations and address issues.
• Evaluate the quality and integrity of site practices related to protocol compliance, patient safety, and regulatory adherence; escalate quality issues when necessary.
• Manage study progress by tracking regulatory submissions and approvals, enrollment status, CRF completion, and data query resolution; may support study start-up activities when required.
• Ensure essential documents are complete and properly filed within the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained in compliance with GCP, ICH, and local regulatory requirements.
• Prepare and maintain accurate and timely documentation, including monitoring visit reports, follow-up letters, and action plans.
• Collaborate effectively with cross-functional study team members to support overall project delivery.
• Where applicable, support site-level subject recruitment strategies and site financial management in line with Clinical Trial Agreements and local requirements.

Qualifications

• Bachelor’s degree in a scientific discipline or healthcare field preferred; an equivalent combination of education, training, and experience may be considered.
• Minimum 6 months of on-site monitoring experience in oncology clinical studies is required.
• Previous CRA experience is required.
• Solid understanding of clinical research regulations, including GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge, supported by company-provided training.
• Proficiency in Microsoft Word, Excel, and PowerPoint; ability to work effectively using a laptop and mobile devices.
• Strong written and verbal communication skills, including a good command of English.
• Excellent organizational, time management, and problem-solving skills.
• Ability to establish and maintain effective working relationships with colleagues, line managers, and external stakeholders.

Job Data by YubHub.

Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate

Qualifications:

• Bachelor's Degree in scientific discipline or health care
• Requires at least 9 months of independent on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted in lieu of degree
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Benefits:

• Flexible hybrid work environment, with an office in the heart of Melbourne and Sydney
• Competitive salary with car and health allowances
• Career growth and opportunity across our FSO and FSP models
• Work with skilled Managers across multi-phases clinical trials

Job Data by YubHub.

IQVIA UK's Site Management (multi-sponsor) team is growing and seeking experienced Clinical Research Associates.

We are recognised as a 2026 "Glassdoor Best Place to Work in the UK" and #1 in our category on the 2026 Fortune World's Most Admired Companies list (for the FIFTH consecutive year!).

Apply today and forge a career with greater purpose, make an impact, and never stop learning!

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate and liaise with study team members for project execution support as appropriate

Requirements

• Experience of independent on-site monitoring
• You have successfully managed multiple clinical trial protocols across diverse investigative sites
• In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Life science degree educated or equivalent industry experience
• Flexibility to travel to sites

Please note - this role is not eligible for UK visa sponsorship

Job Data by YubHub.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF), to track site compliance and performance within project timelines.
• Prepare, handle, distribute, file, and archive clinical documentation and reports according to the scope of work and standard operating procedures.
• Conduct periodic reviews of study files for completeness.
• Assist CRAs and RSU with preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Track and manage Case Report Forms (CRFs), queries, and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• High School Diploma or equivalent required.
• 3 years of administrative support experience.
• Equivalent combination of education, training, and experience.
• Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint.
• Written and verbal communication skills, including good command of English language.
• Effective time management and organisational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines, as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Job Data by YubHub.

As a key member of the project team, the Clinical Trial Manager is responsible for conducting clinical studies to meet contractual requirements, in accordance with Standard Operating Procedures (SOPs), policies, and best practices.

Key Responsibilities:

• Ensure the execution of clinical trials for assigned projects, in accordance with regulatory requirements, client requirements, and internal requirements.
• Ensure that project recruitment targets are met and implement appropriate recruitment strategies.
• Contribute to the development of the project risk management plan and manage clinical risks throughout its lifecycle.
• Ensure the quality of clinical trials by identifying quality standards and requirements, planning compliance assessment methods, and monitoring and managing clinical quality issues.
• Manage the clinical aspects of project funding, including the Estimate at Completion (EAC).
• Identify and manage the project's clinical stakeholders, both internal and external, through effective communication and rigorous issue management.
• Collaborate with the clinical team to achieve established objectives.
• Plan the clinical team's resources and talent.
• Lead regular team meetings and communicate effectively to achieve objectives.
• Contribute to professional development by providing feedback to the clinical team's frontline managers on their performance against project tasks.
• Participate, as appropriate, in the development of the clinical delivery strategy for proposals.
• May mentor and train new colleagues during their onboarding.
• May act as a lead clinical manager alongside other clinical managers for the execution of large-scale international clinical trials.
• May participate in site visits, as required, to support project execution.

Requirements:

• Bachelor's degree in health sciences or another scientific discipline required.
• 5 years of experience in clinical research/monitoring or an equivalent combination of education and experience required.
• Basic knowledge of project management practices and terminology required.
• Sound knowledge of regulatory requirements applicable to clinical research, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• In-depth knowledge of protocols and therapeutic aspects.
• Understanding of the financial aspects of projects.

What We Offer:

• Competitive salary
• Opportunity to work with a leading global provider of clinical research services, commercial insights, and healthcare intelligence
• Collaborative and dynamic work environment

About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Job Data by YubHub.

As a Clinical Trial Manager, you will play a vital role in the conduct of clinical trials. You will work closely with clinical teams to contribute to improving patients' lives by accelerating the commercialization of new medicines.

Key Responsibilities:

• Ensure the execution of clinical trials for assigned projects, in accordance with regulatory requirements, client requirements, and internal requirements.
• Ensure that project recruitment targets are met and implement appropriate recruitment strategies.
• Contribute to the development of the project risk management plan and manage clinical risks throughout its lifecycle.
• Ensure the quality of clinical trials by identifying quality standards and requirements, planning compliance assessment methods, and monitoring and managing clinical quality issues.
• Manage the clinical aspects of project funding, including the Estimate at Completion (EAC).
• Identify and manage the project's clinical stakeholders, both internal and external, through effective communication and rigorous issue management.
• Collaborate with the clinical team to achieve established objectives.
• Plan the clinical team's resources and talent.
• Lead regular team meetings and communicate effectively to achieve objectives.
• Contribute to professional development by providing feedback to the clinical team's frontline managers on their performance against project tasks.
• Participate in the development of the clinical delivery strategy for proposals.
• May mentor and train new colleagues during their onboarding.
• May act as a lead clinical manager alongside other clinical managers for the execution of large-scale international clinical trials.
• May participate in site visits, as required, to support project execution.

Requirements:

• Bachelor's degree in health sciences or another scientific discipline required.
• 5 years of experience in clinical research/monitoring or an equivalent combination of education and experience required.
• Basic knowledge of project management practices and terminology required.
• Sound knowledge of regulatory requirements applicable to clinical research, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• In-depth knowledge of protocols and therapeutic aspects.
• Understanding of the financial aspects of projects.

What We Offer:

• Competitive salary
• Opportunity to work with a leading global provider of clinical research services, commercial insights, and healthcare intelligence
• Collaborative and dynamic work environment

Equal Opportunities Employer:

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law.

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

Responsibilities:

• Conduct site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Collaborate with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability
• Provide protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, escalating quality issues as needed
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
• Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Create and maintain documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Collaborate with study team members for project execution support as needed
• Support development of project subject recruitment plans on a per site basis, if applicable
• Manage site finances according to executed clinical trial agreements and retrieve invoices according to local requirements, if applicable

Qualifications:

• Bachelor's degree in a scientific discipline or healthcare
• At least 1 year of on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted in lieu of degree
• Good knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines)
• Good therapeutic and protocol knowledge as provided in company training
• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable)
• Excellent written and verbal communication skills, including good command of English language
• Strong organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Job Data by YubHub.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
• Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
• Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
• Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
• Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a Clinical Research Associate I, you will perform site monitoring visits, work with sites to adapt and drive subject recruitment plans, administer protocol and related study training, evaluate study site practices, manage study progress, and ensure compliance with regulatory requirements.

Responsibilities:

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Evaluate the quality and integrity of study site practices
• Manage the progress of assigned studies
• Ensure copies of site documents are available for filing in the Trial Master File
• Create and maintain documentation regarding site management and monitoring visit findings
• Collaborate with study team members for project execution support

Profile:

• Bachelor's Degree in a scientific discipline or healthcare
• Minimum of 6 months of independent, on-site monitoring experience within a CRO or pharmaceutical environment
• Full professional fluency in both Dutch (minimum C1 level) and English
• Good knowledge of applicable clinical research regulatory requirements
• Organizational and problem-solving skills
• Exceptional interpersonal and cross-cultural communication skills

What we offer:

• Choice of company car or flexible mobility allowance
• Premium technology bundle
• Strong focus on career advancement
• Home office setup support and annual wellness reimbursement
• Comprehensive time-off policy
• Premium benefits package

Job Data by YubHub.

As a Senior Clinical Research Associate at IQVIA Turkey, you will enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our customers.

Your responsibilities will include:

• Performing site selection, initiation, monitoring and close-out visits
• Supporting the development of a subject recruitment plan
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborating with experts at study sites and with client representatives

Qualifications:

• University degree in scientific discipline or health care
• At least 2 years of on-site monitoring experience
• Good knowledge of clinical research regulatory requirements
• Very good computer skills including MS Office
• Excellent command of Turkish and English language
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients
• Flexibility to travel
• Driver's license class B

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Better Work-Life balance, optimal DOS
• Excellent working environment in a stable, international, reputable company
• Company car, mobile phone and attractive benefits package

For candidates able to start before September 2026, a discretionary sign-on bonus of up to 210,000 TRY may be offered, with the final amount confirmed at offer stage, subject to role level and relevant experience.

Job Data by YubHub.

As a Senior Clinical Research Associate, you will perform site monitoring visits, work with sites to adapt and drive subject recruitment plans, administer protocol and related study training, evaluate study site practices, manage study progress, and ensure compliance with regulatory requirements.

Responsibilities:

• Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements
• Work with sites to adapt, drive, and track subject recruitment plans
• Administer protocol and related study training to assigned sites
• Evaluate study site practices and escalate quality issues as needed
• Manage study progress, track regulatory submissions and approvals, and ensure compliance with regulatory requirements

Profile:

• Bachelor's degree in a scientific discipline or healthcare
• Minimum of 3 years of independent, on-site monitoring experience as a CRA
• Full professional fluency in Dutch and English
• Good knowledge of applicable clinical research regulatory requirements
• Organizational and problem-solving skills
• Exceptional interpersonal and cross-cultural communication skills

What we offer:

• Choice of company car or flexible mobility allowance
• Premium technology bundle
• Strong focus on career advancement
• Home office setup support and annual wellness reimbursement
• Comprehensive time-off policy and premium benefits package

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Open to work with vaccine protocols.
• Willingness to travel as required (approximately 30%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

Job Responsibilities

• General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for one or more of the following functions at the country level:

+ Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. + Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. + May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. + Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. + May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget.

Benefits

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Total Self culture – where you can authentically be yourself

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a SMA I at ICON, you will support the management of clinical trial sites by assisting with site monitoring activities, ensuring compliance with study protocols, and maintain high standards of operational efficiency.

What You Will Do:

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include:

• Assisting in the monitoring of clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Supporting site management activities, including documentation preparation, data entry, and tracking site performance metrics.
• Collaborating with cross-functional teams to facilitate communication and address site-related issues effectively.
• Maintaining accurate records of site activities and contributing to the preparation of monitoring reports.
• Participating in training and development initiatives to enhance knowledge and skills in clinical trial management.

Your Profile:

You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research.
• Some experience in clinical research, site management, or related administrative roles is preferred but not mandatory.
• Strong organisational skills and attention to detail, with the ability to manage multiple tasks effectively.
• Basic knowledge of clinical trial processes and regulatory requirements is a plus.
• Excellent communication and interpersonal skills, with the ability to work collaboratively within a team environment.
• Willingness to travel as required (approximately 25%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

Job Data by YubHub.

Your responsibilities will include:

• Performing site selection, initiation, monitoring and close-out visits
• Supporting the development of a subject recruitment plan
• Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
• Collaborating with experts at study sites and with client representatives
• Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices)
• Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included

Qualifications:

• University Degree in life science or other scientific discipline or apprenticeship in the health care field
• Minimum of two years of on-site monitoring experience
• Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment
• Fluency in German on at least C1 level and a good command of English
• Flexibility to travel up to 40-60% of working time
• Driver's license class B

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Dynamic work environments that expose you to new experiences
• Home-office, company car, accident insurance and more
• Monthly gross salary: starting at 4,200 EUR basic - an overpay according to skills and working experience is possible

Job Data by YubHub.

The successful candidate will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.

Key responsibilities include:

• Conducting on-site and remote monitoring of clinical research studies
• Developing and implementing tools, procedures, and processes to ensure quality monitoring
• Contributing to the design, implementation, and delivery of processes, programs, and policies
• Managing defined components of projects or processes within the area of responsibility
• Ensuring accurate and timely documentation of monitoring activities and findings
• Collaborating with cross-functional teams to support clinical trial operations

The ideal candidate will have:

• A Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications and skills:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred
• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

The successful candidate will be responsible for:

• Processing and reporting individual case safety reports (ICSRs)
• Literature screening and review for safety
• Drug coding using Medical Dictionary for Regulatory Activities (MedDRA)
• Data management activities, including cleaning and validation of data
• Preparation of expedited and periodic safety reports

The ideal candidate will have experience in a pharmacovigilance setting and knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).

Syneos Health is committed to building an inclusive culture where employees can authentically be themselves.

The company offers various benefits, including career development and progression opportunities, technical and therapeutic area training, and a total rewards program.

Job Data by YubHub.

Responsibilities:

• Collaborate with physicians, nurses, and other medical team members to support coordinated participant care.
• Deliver basic and advanced medical care to study participants in emergent and non-emergent situations.
• Lead resuscitation and stabilization efforts for participants experiencing life-threatening situations.
• Monitor, document, and review active Adverse Events (AEs); communicate significant findings to the investigator and support ongoing safety assessments.
• Administer medications and treatments as prescribed by the investigator or physician and in accordance with study protocols.
• Perform technical procedures as needed, including blood collection, vital sign measurement, ECGs, and other delegated clinical activities.
• Assess participants with out-of-range values for associated signs or symptoms, initiate appropriate interventions, and promptly notify the investigator when clinically indicated.
• Conduct all study-related activities in accordance with study protocols, Good Clinical Practice (GCP), and Fortrea policies and standard operating procedures (SOPs).
• Accurately and contemporaneously document study procedures, participant observations, adverse events, interventions, and other required data in source documents and applicable systems.

Requirements:

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
• 2+ years as a Paramedic, preferred.
• State-licensing or certification as a Paramedic.
• Advanced Cardiac Life Support (ACLS) certification.
• Strong Paramedic skills in all areas, including airway management, I.V. establishment, and subcutaneous injections.
• Strong interpersonal and communication skills.
• Ability to effectively manage multiple complex tasks and emergency medical situations.
• Ability to learn and apply study protocols, GCP, site SOPs, Standing Orders, and applicable regulatory requirements.

Work Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids.
• Personal protective equipment required such as protective eyewear, garments, and gloves.

Physical Requirements:

• Ability to work in an upright and/or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

Benefits:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO)
• Employee recognition awards
• Multiple ERG's (employee resource groups)

Job Data by YubHub.

As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

What You Will Do:

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience of working independently and guiding others. Required qualifications and experience:

• A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing, or Biological Science.
• 3-5 years of CRA monitoring experience in CRO/pharma environments.
• Strong preference for at least 1 year of medical device monitoring experience; however, complex pharma monitoring experience will be considered.
• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• A well-executed plan for communication with the study teams and sites.
• Well-versed in clinical trial management; rigorous, detail-oriented, and precise in reports.
• Willingness to travel as required (approximately 60%).

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Job Data by YubHub.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development, and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a SMA I at ICON, you will support the management of clinical trial sites by assisting with site monitoring activities, ensuring compliance with study protocols, and maintaining high standards of operational efficiency.

Responsibilities

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include:

• Assisting in the monitoring of clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Supporting site management activities, including documentation preparation, data entry, and tracking site performance metrics.
• Collaborating with cross-functional teams to facilitate communication and address site-related issues effectively.
• Maintaining accurate records of site activities and contributing to the preparation of monitoring reports.
• Participating in training and development initiatives to enhance knowledge and skills in clinical trial management.

Your Profile

You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research.
• Some experience in clinical research, site management, or related administrative roles is preferred but not mandatory.
• Strong organisational skills and attention to detail, with the ability to manage multiple tasks effectively.
• Basic knowledge of clinical trial processes and regulatory requirements is a plus.
• Excellent communication and interpersonal skills, with the ability to work collaboratively within a team environment.
• Willingness to travel as required (approximately 25%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Benefits may vary depending on role and location.

Job Data by YubHub.

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

The Global Biostatistics team at IQVIA is experienced in submissions for all major regions and works closely with key groups such as Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing to drive efficiency and accountability.

As an Associate Director, Biostatistics, you will manage a team of Biostatistics staff and serve as a site head or functional head within a site. Your responsibilities will include:

• Providing direction and guidance in carrying out project assignments
• Interfacing with clients and other internal departments
• Applying advanced statistical methods to project work
• Serving as a resource for the department to ensure scientific integrity in the application of statistical methodology to clinical trials
• Assisting the Director in strategic planning and resource allocation for the department
• Participating in oversight across studies and/or customers, including guidance on documentation and output development/review
• Assisting the Director in proposal development, project allocation, budget projections, and client presentation, as needed

To be successful in this role, you will need:

• A BSc or MSc degree in Biostatistics or a related field
• 10+ years of relevant experience within the life-science industry, with at least 2 years of experience in managing staff
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
• In-depth knowledge of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Strong working knowledge of SAS
• Working knowledge of relevant Data Standards, such as CDISC/ADaM

In return for your hard work and dedication, we offer:

• Global exposure
• Variety of therapeutic areas
• Collaborative and supportive team environment
• Access to cutting-edge in-house technology
• Excellent career development and progression opportunities
• Work-Life Balance

Job Data by YubHub.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical Study Team Assistant - Patient Recruitment at ICON, you will support the management of clinical trial sites by assisting with site monitoring activities, ensuring compliance with study protocols, and maintain high standards of operational efficiency.

Responsibilities

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include:

• Assisting in the monitoring of clinical trial sites, ensuring adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Supporting site management activities, including documentation preparation, data entry, and tracking site performance metrics.
• Collaborating with cross-functional teams to facilitate communication and address site-related issues effectively.
• Maintaining accurate records of site activities and contributing to the preparation of monitoring reports.
• Participating in training and development initiatives to enhance knowledge and skills in clinical trial management.

Your Profile

You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience:

• Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research.
• Some experience in clinical research, site management, or related administrative roles is preferred but not mandatory.
• Strong organisational skills and attention to detail, with the ability to manage multiple tasks effectively.
• Basic knowledge of clinical trial processes and regulatory requirements is a plus.
• Excellent communication and interpersonal skills, with the ability to work collaboratively within a team environment.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Job Data by YubHub.

Responsibilities:

• Conduct on-site and remote monitoring of clinical research studies
• Develop and implement tools, procedures, and processes to ensure quality monitoring
• Contribute to the design, implementation, and delivery of processes, programs, and policies
• Manage defined components of projects or processes within the area of responsibility
• Ensure accurate and timely documentation of monitoring activities and findings
• Collaborate with cross-functional teams to support clinical trial operations

Qualifications:

• Bachelor's degree in a related field or equivalent experience
• Minimum of 2-4 years of experience in clinical research monitoring
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple priorities
• Proficiency in using clinical trial management systems and other relevant software

Certifications:

• Certified Clinical Research Associate (CCRA) or equivalent certification preferred

Necessary Skills:

• Attention to detail and strong analytical skills
• Problem-solving abilities and critical thinking
• Ability to work effectively in a team environment
• Strong organizational and time management skills
• Proficiency in Microsoft Office Suite

Job Data by YubHub.

A Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. You will report to the Clinical Development Lead.

Responsibilities:

• Contribute to project team discussions on indication planning and incorporate input from across disciplines to support vital deliverables.
• Provide effective support to the development and execution of the Integrated Evidence Strategy (IES).
• Design and execute clinical development plans across advanced stages of development.
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols.
• Input to, and may lead, regulatory interactions and documents.
• Provide medical monitoring and oversight of the safety of study participants.
• Act as clinical lead for a clinical study.
• Make significant contributions to global regulatory submissions/files.
• Evaluate specific business development activities.
• Stay abreast of advancements in therapeutic area research.

Requirements:

• Medical degree
• Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care / Family Medicine.
• Completion of a full clinical residency program leading to board qualification or certification.
• Experience working in the pharmaceutical industry in clinical drug development.
• Direct experience with in-stream medical oversight activities during trial conduct.
• Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.

Preferred Qualifications:

• Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology.
• Familiarity or experience in MASH or ALD drug development.
• Clinical research experience in hepatology.
• Experience with site-facing interactions.
• Demonstrated ability to lead line or matrix teams.
• Experience engaging with regulators, payors, and prescribers.

Benefits:

• Annual base salary ranging $222,750 to $371,250.
• Annual bonus and eligibility to participate in share-based long-term incentive program.
• Health care and other insurance benefits.
• Retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Job Data by YubHub.

You will lead on clinical trial monitoring tasks requiring technical depth, with a focus on quality and continuous improvement. Key responsibilities include:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

You will have a strong foundation in clinical trial monitoring, with the experience to work independently and guide others. Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Willingness to travel as required (approximately 60%)

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance-related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Job Data by YubHub.

As a Senior Clinical Research Associate (CRA) at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.

Responsibilities:

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Your Profile:

• Advanced degree in a relevant field such as life sciences, nursing, or medicine.
• Extensive experience as a Clinical Research Associate, (7+ years' minimum required) with a strong understanding of clinical trial processes and regulatory requirements.
• At least 2 years' experience working on Oncology studies.
• Proven ability to manage multiple sites and projects simultaneously, with strong organisational and problem-solving skills.
• Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license.

Rewards & Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.

Job Data by YubHub.

We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits,selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence.
• Work closely with cross-functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1 year of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

Job Data by YubHub.