Clinical Project Associate

Clinical Project Associate

Cambridge, MA

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
• Assist with vendor and site invoice review as well as budget management and tracking.
• 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.
• Help to ensure the Trial Master File (TMF) is up-to-date and inspection ready.
• 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.
• 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).
• Familiar with GCP and ICH Guidelines and the application to the conduct of clinical trials
• Motivated self-starter who can flourish in a fast-paced small company environment.
• Creative problem-solver with excellent communication and public speaking skills.
• Familiar with MS Office products (MS Project, Excel and Power Point)
• Strong interpersonal and organizational skills, with a high degree of attention to detail.
• Demonstrated ability to manage multiple competing tasks and demands

Estimated Salary Range: [$61,000 - $87,000].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.

About Relay Therapeutics:

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!