Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as a Senior Clinical Research Coordinator. You'll play a pivotal role in advancing medical breakthroughs while ensuring compliance with FDA regulations and ethical standards. Our collaborative environment offers competitive benefits, professional development opportunities, and the chance to make a tangible impact on patient lives.
Responsibilities
- Design, implement, and monitor Phase II-III clinical trials across diverse therapeutic areas
- Coordinate site initiation, recruitment, and maintenance of study protocols
- Ensure regulatory compliance through FDA, ICH-GCP, and institutional guidelines
- Manage electronic data capture systems and conduct source data verification
- Liaise with investigators, sponsors, and ethics committees
- Analyze and report adverse events and protocol deviations
- Mentor junior research staff and optimize trial workflows
Qualifications
- Master's degree in Clinical Research, Nursing, or related field (PhD preferred)
- 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Strong knowledge of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional project management and problem-solving skills
- Experience with oncology or rare disease trials highly desirable