Responsibilities:

• Manage clinical trials from development to implementation
• Collaborate with principal investigators, research subjects, client teams, and clinic operations teams
• Track study progress and ensure alignment with project milestones and client deliverables
• Oversee site management, clinical monitoring, and central monitoring deliverables
• Identify and mitigate risks to clinical trial management deliverables
• Develop and maintain clinical study tools and templates
• Coordinate training for study teams
• Ensure quality of clinical monitoring and site management deliverables

Requirements:

• Bachelor's degree or RN in a related field
• Demonstrated ability to lead and align teams
• Experience in site management and monitoring
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong communication and problem-solving skills
• Moderate travel required (approximately 20%)

Job Data by YubHub.

The successful candidate will oversee negotiations of clinical study agreements, provide oversight of contact and budget negotiations status, and act as a first-line subject matter expert for all CTA elements on assigned studies.

Responsibilities:

• Oversees negotiations of clinical study agreements on a study level and drives CTA document finalization and execution
• Provides oversight of contact and budget negotiations status and manages escalation of out-of-parameter queries
• Acts as first-line subject matter expert for all CTA elements on assigned studies
• Plans contract execution strategy for assigned studies and coordinates with internal study team stakeholders
• Coordinates communications between study team stakeholders and global team of site-facing site contract and budget negotiators
• Works closely with internal stakeholders and with Sponsor to prepare site contractual templates
• Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program
• Creates and maintains document status reports and updates department tools/systems and team members on a regular basis
• Collaborates with internal and external legal, finance and clinical operations departments
• Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms
• May support BU and organization through help desk and other defined pathways to resolve and deescalate issues
• Performs other work-related duties as assigned

Requirements:

• BS degree in life sciences, a health related field, or equivalent combination of education and experience
• Preferred experience in a CRO/pharmaceutical industry and related clinical trial expertise
• Thorough knowledge of applicable regulations, drug development and clinical project management procedures
• Good presentation, documentation and interpersonal skills
• Proficient in MS Office, MS Project, outlook and Internet
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment
• Attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines

Job Data by YubHub.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
• Verify the process of obtaining informed consent has been adequately performed and documented
• Assess factors that might affect subject/patient's safety and clinical data integrity
• Apply query resolution techniques remotely and on site
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required
• Understand project scope, budgets, and timelines for own and others' activities in the clinical team
• Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• Act as primary liaison with project site personnel
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• May provide training or mentorship to more junior level CRAs

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.

The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.

Key responsibilities include:

• Evaluating site performance and providing recommendations for site-specific actions
• Verifying informed consent processes and protecting subject/patient confidentiality
• Assessing site processes and conducting source document reviews
• Applying query resolution techniques and providing guidance to site staff
• Managing investigational product inventory and verifying dispensing and administration
• Reviewing investigator site files and ensuring compliance with regulations
• Documenting activities and supporting subject/patient recruitment and retention
• Understanding project scope, budgets, and timelines
• Acting as a primary liaison with project site personnel
• Providing guidance on audit readiness standards
• May provide training or mentorship to junior CRAs

Requirements:

• Bachelor's degree or RN in a related field or equivalent experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75%

Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.

Job Data by YubHub.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Verify the process of obtaining informed consent has been adequately performed and documented
• Assess factors that might affect subject/patient's safety and clinical data integrity
• Apply query resolution techniques remotely and on site
• Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
• Verify site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems as required
• Understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met
• May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings
• Provide guidance at the site and project level towards audit readiness standards
• Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes

Qualifications:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Job Data by YubHub.

As a Sr CRA, you will perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key responsibilities include:

• Evaluating site performance and providing recommendations for site-specific actions
• Verifying informed consent processes and protecting subject/patient confidentiality
• Assessing site processes and conducting source document reviews
• Resolving queries and providing guidance to site staff
• Managing site-level activities and communication to meet project objectives
• Preparing for and attending investigator meetings and sponsor face-to-face meetings
• Providing guidance on audit readiness standards and supporting preparation for audits
• May involve direct supervision, training, and mentorship of junior CRAs

Requirements:

• Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

Syneos Health offers a dynamic work environment where you can develop your skills and advance your career.

Job Data by YubHub.