Job Description
Join our pioneering team at MediVance Biologics, where innovation meets compassionate care. We're seeking a Senior Clinical Research Coordinator to drive our next-generation oncology trials forward. In this high-impact role, you'll orchestrate complex multi-site studies while mentoring junior staff and ensuring regulatory excellence. Our state-of-the-art Boston facility offers unparalleled resources for transformative medical research.
Responsibilities
- Design and execute Phase I-III clinical trials with 15+ investigational sites
- Oversee protocol development, IRB submissions, and FDA compliance
- Lead cross-functional teams including biostatisticians and data managers
- Manage $2M+ research budgets and vendor relationships
- Train investigators on GCP guidelines and study procedures
- Analyze adverse events and safety data for regulatory reporting
- Present findings at national conferences and peer-reviewed journals
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years coordinating oncology or immunotherapy trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven experience with FDA audits and 157 inspections
- Expertise in EDC systems (Medidata Rave, Oracle RDC)
- Strong knowledge of ICH-GCP and 21 CFR regulations
- Exceptional stakeholder management across global sites
- Track record of 3+ successful IND/BLA submissions