Job Description
Join Boston Medical Center's prestigious research division as a Clinical Research Coordinator and drive groundbreaking medical innovations. We're seeking a detail-oriented professional to manage complex clinical trials, ensuring compliance with FDA protocols while advancing patient care through cutting-edge research. This role offers unparalleled opportunities to collaborate with leading physicians and contribute to life-changing medical breakthroughs in a dynamic, mission-driven environment.
Responsibilities
- Oversee end-to-end clinical trial execution including protocol development, site management, and regulatory compliance
- Coordinate multi-disciplinary research teams, ensuring seamless collaboration between physicians, nurses, and data specialists
- Implement rigorous quality control measures for data collection, monitoring, and reporting procedures
- Manage Investigational Drug accountability, ensuring strict adherence to GCP guidelines and institutional policies
- Develop and maintain comprehensive trial documentation including informed consent forms, case report forms, and regulatory submissions
- Analyze and interpret clinical data, preparing detailed reports for FDA submissions and internal review boards
- Train clinical staff on research protocols and regulatory requirements to maintain trial integrity
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 3+ years of clinical research coordination experience with FDA-regulated trials
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Expertise in ICH-GCP, FDA 21 CFR Part 820, and HIPAA compliance protocols
- Advanced proficiency in clinical trial management software (e.g., Medidata Rave, Oracle CTMS)
- Exceptional attention to detail with demonstrated success in managing complex data sets
- Strong written communication skills with experience preparing regulatory documentation
- Ability to work effectively in fast-paced environments with competing priorities