Job Description
Join Boston Medical Center's prestigious research division as a Senior Clinical Research Coordinator and drive innovation in patient care. We're seeking a dedicated professional to oversee complex clinical trials in oncology, ensuring compliance with FDA regulations and ethical standards. This role offers competitive benefits, including comprehensive health coverage, retirement plans, and opportunities for professional development in a cutting-edge healthcare environment.
Responsibilities
- Manage end-to-end clinical trial operations for Phase II-III oncology studies
- Ensure protocol adherence and regulatory compliance (FDA, ICH-GCP)
- Coordinate with IRB for ethics approvals and protocol amendments
- Train and supervise junior research staff and study coordinators
- Oversee data integrity through source documentation and CRF management
- Liaise with pharmaceutical sponsors and CROs for study milestones
- Develop patient recruitment strategies and maintain enrollment logs
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 5+ years of clinical trial coordination experience in oncology
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Proven expertise in FDA 21 CFR Part 11 compliance
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Strong knowledge of ICH-GCP and clinical research ethics
- Exceptional organizational skills with attention to detail