Job Description
Join Boston Medical Research Institute's prestigious clinical trials division as a Senior Clinical Research Coordinator. Lead groundbreaking studies in oncology and immunotherapy while ensuring compliance with FDA regulations and GCP standards. Collaborate with multidisciplinary teams to advance patient care through innovative research protocols.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol development to final report submission
- Recruit, screen, and monitor 50+ research participants with complex medical histories
- Manage regulatory documentation (IRB submissions, informed consent forms, adverse event reporting)
- Train and mentor junior research staff on SOPs and study procedures
- Analyze clinical data using SAS and R statistical software packages
- Liaise with pharmaceutical sponsors and CROs for protocol amendments and budget negotiations
Qualifications
- Master's degree in Nursing, Public Health, or Clinical Research with 5+ years' experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Expertise in oncology trial management and biorepository sample handling
- Proficient in electronic data capture systems (Medidata Rave, Oracle RDC)
- Demonstrated success in FDA audit preparation and site management
- Strong statistical literacy and experience with clinical trial design methodologies