Job Description
Join our pioneering team at MediGenix Innovations, a leader in cutting-edge clinical trials for rare diseases. We're seeking a Senior Clinical Research Coordinator to manage pivotal studies at our state-of-the-art Boston facility. You'll collaborate with world-class physicians and contribute to breakthrough therapies while enjoying comprehensive benefits including health insurance, 401(k) matching, and professional development stipends.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to FDA submission
- Coordinate multi-center studies with global research sites and CRO partners
- Ensure strict compliance with GCP, ICH guidelines, and regulatory standards
- Lead data management activities including CRF review and database validation
- Mentor junior staff and optimize research workflows
- Present findings to internal stakeholders and regulatory authorities
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience in oncology/neurology
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong knowledge of FDA 21 CFR Part 11 and HIPAA regulations
- Exceptional project management and cross-functional communication skills
- Experience managing studies with complex endpoints and biomarker analysis