Senior Clinical Project Associate

The Opportunity: As Senior 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 integrated 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.

• You will support the day-to-day operations of clinical trial execution, with a focus on site start-up,

study participant enrollment, clinical monitoring, drug supply planning, defining clinical supply logistics, GCP and protocol compliance, from the clinical sites, CROs and vendors.

• You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from

study initiation through study closure.

• You will maintain study trackers and provide metrics as needed.
• You will review and contribute to key study documents including, but not limited to, informed

consent forms, case report forms, and study plans.

• You will assist with the preparation and distribution of meeting agendas and minutes as well as

actively participate in team meetings providing updates on your key responsibilities.

• You will help to ensure the Trial Master File 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.

• You have 2-3 years of experience in clinical trial experience. CRO or Sponsor experience is strongly

preferred.

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