Clinical Project Associate

The Opportunity:

As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards.  You will be an integral member of the Relay Tx Clinical Development Operations team making key contributions to the execution of clinical trials that will translate Relay’s innovative science into impactful medicines for patients.

Your Role:

• Partner with Clinical Project Managers to support the day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, GCP and protocol compliance, from the clinical sites, CROs and vendors.
• Serve as a point of contact for CROs, vendors, investigators and clinical site staff to support trial deliverable, effective communication and strong working relationships
• Develop ,maintain and improve study tracking tools
• You will assist with vendor and site invoice review as well as budget management and tracking.
• You will review and contribute to key study documents including, but not limited to, training records, regulatory packets, informed consent forms, case report forms, study oversight committee charters, and study plans.
• Maintain version control and documentation across clinical materials.
•  Coordinate and track trial-specific equipment and supplies, as appropriate.
• Coordinate trial team meetings, including schedules, distribution, agendas, minutes and action items as well as actively participate in team meetings providing updates on your key responsibilities.
• You will help to ensure the Trial Master File (TMF) is up-to-date and inspection ready.
• You will support inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.
• You will actively participate in the development of department initiatives; contribute ideas to department initiatives that will make a difference to the efficiency and effectiveness of Clinical Operations.

Your Background:

• Bachelor’s degree with at least 2+ years of relevant clinical trial experience (e.g. CRO, Sponsor experience, clinical site or clinical trial vendor).
• You are familiar with GCP and ICH Guidelines and the application to the conduct of clinical trials
• You are a motivated self-starter who can flourish in a fast-paced small company environment.
• You are a creative problem-solver with excellent communication and public speaking skills.