Senior Clinical Trial Committee Coordinaor

The Senior Clinical Trial Committee Coordinator leads complex committee operations across multiple studies or therapeutic areas. This role provides subject‑matter expertise, mentors junior coordinators, and partners with leadership to enhance committee governance, quality, and compliance.

Responsibilities:

• Oversee the proper functioning of CPC’s suite of committees.
• Work closely with the Director and Associate Director of Operations to ensure overall quality of project services, proactive issue resolution, and development of systems to standardize and improve committee coordination.
• Serve as a mentor to other Clinical Trial Committee Coordinators, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
• Lead process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of Sponsor deliverables.
• Define and monitor project scope, timelines, and deliverables from project initiation to close-out in collaboration with the Director and Associate Director of Operations.
• Lead the development, review, and testing of adjudication databases in collaboration with Data Management.
• Participate in the development, review, and testing of clinical trial databases.
• Provide expert advice in the design, writing, and/or review of project-related committee documents including project management plans, committee charters, case report forms, site manuals, site newsletters, resource tools, monitoring plans, and report templates.
• Oversee committee metrics (e.g., adjudication metrics) and necessary escalations.
• Provide necessary updates and reports to the Sponsor as outlined by the contract.
• Work with the business development team on budgets, proposals, and change orders.
• Oversee DMC and EAC operations for high complexity or high visibility studies.
• Ensure audit ready documentation and guide teams through regulatory expectations.
• Facilitate sensitive or unblinded meetings, ensuring independence and confidentiality.
• Oversee complex safety reviews, interim analyses, and adjudication workflows.
• Additional activities as required.

Qualifications:

• A nursing or BA/BS in a scientific field (or equivalent knowledge/experience).
• 5 years of experience in a clinical research setting (required).
• 3 years of sponsor or CRO clinical research project/clinical operations management experience with direct committee coordination experience.
• Demonstrated expertise in GCP, regulatory guidance, and committee governance.
• Strong leadership, communication, and problem solving skills.
• Willingness to travel 20-25% of the time.