Job Description
Join Boston Medical Center's groundbreaking Clinical Research Division as we pioneer the next generation of medical breakthroughs. We seek a meticulous Clinical Research Coordinator to orchestrate complex clinical trials while ensuring regulatory compliance and patient safety. This pivotal role bridges cutting-edge science with compassionate patient care in our state-of-the-art facilities.
Responsibilities
- Oversee all phases of clinical trial protocols from IRB submission to final report
- Manage participant recruitment, screening, and informed consent processes
- Maintain accurate electronic data capture systems and regulatory documentation
- Coordinate multidisciplinary teams including investigators, sponsors, and regulatory bodies
- Monitor adverse events and ensure protocol adherence per FDA/ICH guidelines
- Prepare FDA submissions and maintain audit-ready documentation trails
- Leverage REDCap and Medidata Rave for data management and quality assurance
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 3+ years experience coordinating oncology/neurology clinical trials
- Certified Clinical Research Professional (CCRP) certification required
- Expertise in FDA 21 CFR Part 820 and ICH-GCP compliance
- Proficient in electronic data capture systems (EDC) and CTMS platforms
- Exceptional attention to detail with audit documentation experience
- Strong written communication skills for regulatory submissions
- Experience with rare disease or pediatric trial protocols preferred