Clinical Project Associate

Relaytherapeutics; Cambridge (MA); On-site; USD 61,000 - 87,000; Full time

Job summary

Relaytherapeutics is seeking a Clinical Project Associate in Cambridge, Massachusetts. This role involves providing clinical trial coordination support and ensuring compliance with regulatory guidelines.

You'll work closely with Clinical Project Managers and CROs, contribute to study documentation, manage trial budgets, and ensure the Trial Master File is ready for inspection. The ideal candidate has a bachelor's degree and at least 2 years of relevant clinical trial experience.

Qualifications

• 2+ years of clinical trial experience in CRO, Sponsor, or clinical site.
• Familiarity with regulatory guidelines like GCP and ICH.
• Motivated self-starter in a fast-paced environment.

Responsibilities

• Support day-to-day operations of clinical trial execution.
• Serve as a point of contact for CROs, vendors, and clinical staff.
• Maintain study documents and ensure TMF is up-to-date.
• Coordinate trial team meetings and provide updates.

Skills

Clinical trial coordination

GCP and ICH Guidelines

Communication skills

MS Office

Problem-solving

Attention to detail

Organizational skills

Education

Bachelor's degree

Job description

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 deliverables, 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 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, and 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.
• Pragmatic and able to manage multiple competing tasks and demands.

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