Sr. Clinical Research Coordinator, Clinical Operations

Company Overview:

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.  

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com.

Position Overview:

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.

Key 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

Qualifications:

· 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!

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or any other characteristic protected by law.

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.