Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as we pioneer breakthrough treatments for rare diseases. We're seeking a meticulous Senior Clinical Research Coordinator to manage complex multi-center studies and ensure regulatory compliance. Enjoy competitive benefits, professional development opportunities, and the chance to shape the future of medicine.
Responsibilities
- Oversee protocol implementation across 5+ clinical sites
- Manage IRB submissions and regulatory documentation
- Coordinate investigator meetings and training sessions
- Monitor patient enrollment and data integrity
- Conduct site visits and ensure GCP compliance
- Prepare FDA submissions and safety reports
- Liaise with sponsors and regulatory authorities
Qualifications
- BSN or Master's in Clinical Research/Health Sciences
- 5+ years coordinating Phase II-III trials
- Certified Clinical Research Professional (CCRP)
- Experience with rare disease protocols preferred
- Expertise in EDC systems (Medidata Rave)
- Strong knowledge of 21 CFR Part 11 and ICH-GCP
- Exceptional project management skills