Senior Clinical Project Associate

Relay Therapeutics•Cambridge, MA
•$69,000 - $99,000

About The Position

The Senior Clinical Project Associate provides clinical trial coordination support and implements operational plans in accordance with regulatory guidelines and ICH/GCP standards. As an integrated member of Relay Therapeutics’ Clinical Development Operations team, the role contributes to clinical trial execution to help translate the company’s science into medicines for patients. The position supports day-to-day clinical trial operations, including site start-up, participant enrollment, clinical monitoring, drug supply planning and logistics, and GCP and protocol compliance across clinical sites, CROs, and vendors. The associate coordinates with the CRO and the Relay Tx Clinical Operations Lead from study initiation through study closure, maintains study trackers and metrics, contributes to study documents, and supports team meetings and Trial Master File readiness. The role also helps prepare for and respond to audits and inspections and contributes to department initiatives intended 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 clinical trial conduct.
  • Ability to work 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 MS Office products, including MS Project, Excel, and PowerPoint.
  • Strong interpersonal and organizational skills, with a high degree of attention to detail.
  • Ability to pragmatically manage multiple projects and needs effectively.

Nice To Haves

  • CRO or Sponsor experience is strongly preferred.

Responsibilities

  • Support day-to-day clinical trial execution, 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 Tx Clinical Operations Lead to support planning from study initiation through study closure.
  • Maintain study trackers and provide metrics as needed.
  • Review and contribute to study documents, including informed consent forms, case report forms, and study plans.
  • Assist with preparing and distributing meeting agendas and minutes, participate in team meetings, and provide updates on assigned responsibilities.
  • 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 developing department initiatives and contribute ideas to improve Clinical Operations efficiency and effectiveness.
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