Clinical Project Associate

Role Summary

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 integrated member of the Relay Tx Clinical Development Operations team contributing to the execution of clinical trials that translate Relay’s science into medicines for patients.

Responsibilities

• You will 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.
• 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 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, informed consent forms, case report forms, study oversight committee charters, 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.

Qualifications

• Required: 1‚Äì2 years of experience in clinical trials (CRO or Sponsor experience strongly preferred).
• Required: Familiar with GCP and ICH guidelines and their application to the conduct of clinical trials.
• Required: Motivated self-starter able to flourish in a fast-paced small company environment.
• Required: Creative problem-solver with excellent communication and public speaking skills.
• Required: Proficient with MS Office products (MS Project, Excel, PowerPoint).
• Required: Strong interpersonal and organizational skills with high attention to detail.
• Required: Pragmatic and able to manage multiple projects and needs effectively.