Senior Clinical Project Associate

Relay Therapeutics • Cambridge, MA

8d

About The Position

As Senior Clinical Project Associate, you will provide clinical trial coordination support and implement operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Therapeutics Clinical Development Operations team, contributing to the execution of clinical trials that translate the company’s science into medicines for patients.

You will support day-to-day clinical trial operations, including site start-up, participant enrollment, clinical monitoring, drug supply planning, clinical supply logistics, and GCP and protocol compliance across clinical sites, CROs, and vendors. In coordination with the CRO and Relay Therapeutics Clinical Operations Lead, you will support study planning from initiation through closure; maintain study trackers and provide metrics; review and contribute to study documents; and help prepare meeting agendas and minutes. You will participate in team meetings, keep the Trial Master File current and inspection ready, and support inspection readiness activities with CROs and clinical sites. You will also contribute ideas and participate in department initiatives to improve Clinical Operations efficiency and effectiveness.

Requirements

• 2–3 years of clinical trial experience.
• Familiarity with GCP and ICH Guidelines and their application to the conduct of clinical trials.
• Ability to thrive as a motivated self-starter in a fast-paced small-company environment.
• Creative problem-solving ability and excellent communication and public speaking skills.
• Familiarity with Microsoft Office products, including MS Project, Excel, and PowerPoint.
• Strong interpersonal and organizational skills and a high degree of attention to detail.
• Pragmatism and ability to manage multiple projects and needs effectively.

Nice To Haves

• CRO or sponsor experience is strongly preferred.

Responsibilities

• Support day-to-day clinical trial operations, including site start-up, study participant enrollment, clinical monitoring, drug supply planning, clinical supply logistics, and GCP and protocol compliance.
• Coordinate with the CRO and Relay Therapeutics Clinical Operations Lead to support planning from study initiation through study closure.
• Maintain study trackers and provide metrics as needed.
• Review and contribute to key study documents, including informed consent forms, case report forms, and study plans.
• Assist with preparing and distributing meeting agendas and minutes, and provide updates on key responsibilities during team meetings.
• Help keep the Trial Master File up to date and inspection ready.
• Collaborate with CROs and support clinical sites in preparing for and responding to audit and inspection findings from internal QA and external regulatory agencies.
• Participate in the development of department initiatives and contribute ideas to improve Clinical Operations efficiency and effectiveness.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed