Sr. Clinical Research Coordinator, Clinical Operations

Prime Medicine • Cambridge, MA

2d • Hybrid

About The Position

Join a collaborative, agile and dynamic Clinical Development Operations (CDO) team by leading and contributing to transformative clinical programs for patients in rare diseases and beyond.
In this position, you will be hands-on in day-to-day study execution, working closely with internal study team members, clinical sites, and external CROs and vendors. This position is ideal for someone who thrives in a fast-paced, evolving environment, is comfortable wearing multiple hats, and is eager to learn more about clinical trial management and execution. This is a hybrid role requiring a combination of in-office presence (Watertown, MA) and remote work, with expectations aligned to team and business needs.

Requirements

• BS/BA/RN Degree in science or a health-related field is preferred
• Minimum 2–4 years of clinical research experience; sponsor experience is strongly preferred.
• Familiarity with clinical trial operations, ICH-GCP, and regulatory requirements
• Experience and understanding of EDC systems, TMF systems, and clinical trial documentation
• Familiarity with clinical data review and data management processes, including Data Monitoring Committees
• Highly organized with strong attention to detail
• Ability to manage multiple priorities with a sense of urgency in a fast-paced environment
• Strong communication and relationship-building skills
• Resourceful, proactive problem-solver with a “do-what-it-takes” mindset
• Comfortable operating in a dynamic environment with evolving processes and priorities
• Self-motivated, collaborative, and able to work both independently and cross-functionally
• Positive, team-oriented attitude with a passion for advancing innovative therapies for patients
• Excitement to contribute to Prime Medicine’s culture!

Responsibilities

• Support the execution of clinical trials from startup through closeout, ensuring adherence to protocol, timelines, and quality standards
• Assist with site startup activities, including regulatory document collection, IRB/EC submissions, and site readiness/activation
• Support development of study and site-facing materials (e.g., ICFs, recruitment materials, study manuals, CCGs, study tools) and coordinate cross-functional review and approval
• Prepare and maintain meeting minutes, action items, and follow-ups for key study team meetings
• Maintain study documentation (e.g., sponsor TMF oversight and ISF support) to ensure completeness, quality, and inspection readiness
• Oversee CRO/vendor TMF activities, ensuring alignment with sponsor expectations, TMF plans, and filing timelines
• Track study progress, enrollment, IRB/EC submissions and queries, and key operational metrics; proactively identify and escalate risks to timelines or deliverables
• Serve as a primary point of contact for CRAs and sites to address day-to-day operational questions and issues
• Track and monitor key subject visits and study milestones to ensure protocol compliance and data integrity
• Support inspection readiness activities, including TMF reviews, audit support, and resolution of findings
• Support clinical sample management activities, including coordination of central labs, sample logistics, tracking, and issue resolution
• Review clinical data, monitoring reports, and protocol deviations to ensure quality, compliance, and timely issue resolution
• Contribute to SOP development, process improvements, and operational best practices within a growing organization

Benefits

• Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees