Job Description
Join Boston's premier medical research institute at the forefront of groundbreaking clinical trials. We're seeking a meticulous Clinical Research Coordinator to accelerate medical innovation while ensuring regulatory excellence. Enjoy competitive compensation, comprehensive benefits, and the opportunity to collaborate with world-class physicians in a state-of-the-art facility.
Responsibilities
- Oversee end-to-end clinical trial management including protocol development and site coordination
- Ensure strict adherence to FDA regulations, GCP guidelines, and IRB protocols
- Recruit, screen, and enroll study participants while maintaining ethical standards
- Manage electronic data capture systems and maintain accurate regulatory documentation
- Coordinate multi-disciplinary research teams and external vendor relationships
- Monitor adverse events and ensure timely safety reporting to regulatory bodies
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field required (Master's preferred)
- 3+ years clinical research coordination experience in hospital/pharma setting
- Certified Clinical Research Professional (CCRP) certification mandatory
- Expertise in FDA 21 CFR Part 11, ICH-GCP, and HIPAA compliance
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Demonstrated success in complex protocol management and patient recruitment
- Exceptional attention to detail and crisis management capabilities