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
- Maintain compliance with study protocols, GCP/ICH guidelines, FDA regulations, IRB policies, and company SOPs
- 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
- Maintain working knowledge of study protocols, laboratory manuals, equipment calibration, and inventory control
Requirements
- High school diploma or GED required
- At least one full year of experience coordinating clinical trials phases 1-4 required
- 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
Nice to Have
- Bachelor's Degree preferred
- Industry-sponsored trial experience strongly preferred
- Vaccine study experience a plus
- Previous hands-on clinical experience caring for patients suffering from neurodegenerative diseases highly preferred
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
Work Arrangement
On-site
Team
Structure: Part of a growing clinical trial research site focused on neurodegenerative diseases, memory and movement disorders, operating within a network of 20+ sites across the US and Canada.. Reports to: Site Manager
Additional Information
- Schedule: Mondays through Fridays, 8:00am - 5:00pm
- Location: Onsite in Plymouth, MA (no capabilities for remote or hybrid work)
- Reports to: Site Manager
- Pay Range: Competitive and negotiable; based on years of experience as a CRC in clinical research trials.
