Job Description
Join Boston Medical Center's cutting-edge research division as a Clinical Research Coordinator and drive breakthroughs in patient care. We seek a meticulous professional to manage clinical trials, ensuring compliance with FDA regulations while fostering collaboration between multidisciplinary teams. This role offers the opportunity to contribute to life-changing medical advancements in a dynamic, academic medical center environment.
Responsibilities
- Oversee all aspects of clinical trial protocols including patient recruitment, enrollment, and retention
- Ensure strict adherence to GCP guidelines, FDA regulations, and institutional IRB requirements
- Manage electronic data capture systems and maintain accurate regulatory documentation
- Coordinate with principal investigators, physicians, and research staff to execute study protocols
- Monitor adverse events and ensure timely reporting to regulatory authorities
- Prepare regulatory submissions and maintain comprehensive study files
- Train clinical staff on protocol procedures and compliance standards
Qualifications
- Bachelor's degree in Nursing, Health Sciences, or related field (Master's preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Minimum 3 years of clinical research coordination experience in an academic/hospital setting
- Expertise in FDA regulations, ICH-GCP, and 21 CFR compliance
- Proficiency with electronic data capture systems (e.g., REDCap, Medidata Rave)
- Exceptional organizational skills with attention to detail in documentation
- Strong interpersonal abilities for patient interaction and team collaboration