As a Site Activation Specialist, you will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules, with oversight from the SSU Country Manager.

Key responsibilities include:

• Working within forecasted submission/approval timelines and ensuring compliance
• Monitoring basic financial aspects of the project and escalating discrepancies
• Reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Ensuring all relevant documents are submitted to the Trial Master File (TMF)
• Performing various functions at the country level, such as Local Submissions Specialist, Local EC Applications, RA Applications, and Local Site ID and Feasibility Support

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

The ideal candidate will have experience in a similar role and be able to work independently in a fast-paced environment.

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The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

• Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
• Evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions
• Verify process of obtaining informed consent and document confidentiality of each subject/patient
• Assess factors affecting subject/patient's safety and clinical data integrity
• Conduct Source Document Review and verify required clinical data entered in case report form (CRF)
• Apply query resolution techniques and provide guidance to site staff
• Utilize available hardware and software to support clinical study data review and capture
• Perform investigational product (IP) inventory, reconciliation, and reviews storage and security
• Routinely review Investigator Site File (ISF) for accuracy, timeliness, and completeness
• Document activities via confirmation letters, follow-up letters, trip reports, and communication logs
• Support subject/patient recruitment, retention, and awareness strategies
• Enter data into tracking systems to track observations, ongoing status, and assigned action items
• Understand project scope, budgets, and timelines, and manage site-level activities/communication
• May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
• Provide guidance at site and project level towards audit readiness standards

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 adapt to new technologies
• Excellent communication, presentation, and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis

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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

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Responsibilities:

• Lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Produce site-specific contracts from country clinical trial agreement (CTA) template.
• Review and own site-specific contracts from country template.
• Negotiate budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Perform quality control and arrange execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generate amended contract and/or budget documents as necessary.
• Work closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
• Identify possible contract or process operational risk and proactively work within the team to provide solutions.
• Provide support to business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Collaborate with internal and external legal, finance, and clinical operations departments.
• Maintain and actively support review and development of contract templates, budget templates and site specific files and databases.
• Serve as key communication liaison between site contracts staff and internal and external customers.
• Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs).

Qualifications:

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
• Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Strong organizational skills with proven ability to handle multiple projects.
• Excellent communication, presentation and interpersonal skills.
• Quality-driven in all managed activities.
• Strong negotiating skills.
• Strong problem-solving skills.
• Ability to mentor and motivate more junior staff.
• Demonstrate an ability to provide quality feedback and guidance to peers.

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

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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

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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

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Responsibilities:

• Prepare and submit full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
• Undertake information processing activities with high reliability and quality within tight timelines.
• Complete project-specific activities with minimal supervision within cost and time estimates.
• Prepare records and maintain regulatory databases as per Syneos Health and/or client requirements.
• Conduct Quality Control reviews of documents and track until final submission or delivery to clients.
• Attend client meetings and build client relationships in support of projects and deliverables.
• Review Regulatory Associates' work, performance, and productivity, and coordinate with project managers and directors.
• Identify risks to project delivery and provide proposals for issue resolution.
• Assist in training and mentoring team members.
• Maintain individual training records and complete designated required training.

Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

The company offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs. Syneos Health is committed to building an inclusive culture where employees can authentically be themselves.

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The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Job Responsibilities

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings.
• Serves as an escalation point for communications with investigator site staff.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates.
• Coordinates initial and ongoing training to the study team.
• Oversees resourcing allocations for CRAs and Central Monitors.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables.
• Reviews the project oversight dashboards and other clinical trial systems.
• Understands the monitoring strategy required for the study.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with the client and other functional departments.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery.
• Oversees CRAs and Central Monitors assigned to the study.
• Provides feedback to line managers on staff performance.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring.
• Preferred experience with risk-based monitoring.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• Good communication, presentation and interpersonal skills.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem solving techniques to resolve complex issues.
• Moderate travel may be required, approximately 20%.

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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

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The Sample Management Specialist II is responsible for managing samples, including receipt, inventory, chain of custody, storage, transfers, and disposition. The ideal candidate will have experience with end-to-end sample management processes and be skilled in operating and troubleshooting storage appliances and environmental monitoring systems.

Core Responsibilities

• Receive, control, and dispose of study samples and reference materials
• Manage shipping and receiving samples, including destruction and transfer as directed by clients
• Provide samples and materials to laboratory staff for analysis
• Maintain inventory of supplies and order new supplies as needed
• Assist with maintenance, operation, and support of sample storage equipment and monitoring systems
• Archive documents related to sample management

Qualifications

• High school diploma
• Excellent communication, presentation, and interpersonal skills
• Good computer skills, including Microsoft Word and Excel
• Ability to use sample-tracking software
• Bilingualism in English and Spanish, with understanding of simple messages and basic instructions

What We Offer

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

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