Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments for rare diseases. We seek a meticulous Clinical Research Coordinator to orchestrate complex trials while ensuring regulatory compliance and patient safety. Work alongside world-renowned physicians in state-of-the-art facilities, contributing directly to life-changing medical advancements. Enjoy comprehensive benefits including tuition reimbursement, flexible scheduling, and wellness programs.
Responsibilities
- Manage multi-phase clinical trials from protocol development to final report submission
- Recruit, screen, and enroll participants while maintaining strict GCP standards
- Coordinate site visits, audits, and FDA inspections
- Maintain accurate electronic data capture systems and regulatory documentation
- Liaise between sponsors, investigators, and IRB committees
- Train clinical staff on trial protocols and compliance procedures
- Analyze adverse events and ensure timely reporting to regulatory bodies
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 experience in clinical trial coordination
- Proven expertise in FDA regulations and ICH-GCP guidelines
- Advanced proficiency in EDC systems (e.g., Medidata Rave)
- Exceptional attention to detail and documentation skills
- Strong problem-solving abilities in dynamic healthcare environments