Clinical Research Coordinator - General Interest
Headlands Research · Plymouth, MA · 5 mo ago
AnalystFull-time
Responsibilities
- Coordinate all aspects of assigned clinical trials from site initiation to study close-out
- Conduct subject visits and ensure timely, accurate documentation following ALCOA-C standards
- Manage subject recruitment, informed consent, and retention strategies
- Ensure timely data entry and resolution of EDC queries
- Report and follow up on all adverse events, serious adverse events, and deviations
- Collaborate with investigators, lab teams, sponsors/CROs, and internal stakeholders
- Prepare for and participate in monitoring visits, audits, and inspections
- Maintain regulatory documentation and ensure proper training is completed for all study amendments and systems
- Execute study procedures such as phlebotomy, ECGs, and sample processing within scope (as trained)
- Attend investigator meetings and provide cross-functional support as needed
Requirements
- A high school diploma or GED
- Bachelor's degree preferred
- Industry-sponsored trial experience strongly preferred (vaccine study experience a plus)
- At least one full year of experience coordinating clinical trials phases 1-4 required
- Previous hands-on clinical experience caring for patients suffering from neurodegenerative diseases highly preferred
- Familiarity with electronic data capture (EDC), IVRS, and other trial platforms
- Deep understanding of FDA, ICH-GCP regulations, and clinical trial procedures
- Proficiency in medical terminology and clinical documentation practices
- Strong interpersonal, verbal, and written communication skills
- Organized, detail-oriented, and capable of managing multiple priorities
- Proficient in Microsoft Office and other clinical research systems
Benefits
Competitive pay + annual performance incentives
Medical, dental, and vision insurance
401(k) plan with company match
Paid time off (PTO) and company holidays
A mission-driven culture focused on advancing medicine and improving patient outcomes