Sr. Clinical Research Coordinator, Clinical Operations

 

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 environmen