Job Description
Join Boston's premier biomedical research institute as a Clinical Research Coordinator and drive groundbreaking medical discoveries. We're seeking a detail-oriented professional to oversee clinical trials, ensuring regulatory compliance and data integrity. This role offers competitive compensation, comprehensive benefits, and opportunities to advance healthcare innovation in a collaborative, cutting-edge environment.
Responsibilities
- Manage clinical trial protocols, ensuring adherence to FDA regulations and GCP standards
- Coordinate patient recruitment, informed consent processes, and ethical approvals
- Maintain accurate electronic data capture systems and regulatory documentation
- Liaise with investigators, sponsors, and IRB to resolve protocol deviations
- Prepare regulatory submissions and monitor trial progress through to completion
- Train staff on clinical trial procedures and safety protocols
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Minimum 3 years clinical trial coordination experience in therapeutic areas
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Deep knowledge of ICH-GCP, FDA 21 CFR, and international regulatory guidelines
- Exceptional organizational skills with attention to detail and documentation accuracy