Job Description
Join our pioneering team at MediGenix Research Institute, where innovation meets compassionate care. We're seeking a Clinical Research Coordinator to lead groundbreaking studies in oncology therapeutics. As a vital member of our multidisciplinary team, you'll contribute to life-changing medical advancements while working in our state-of-the-art Boston facility.
Responsibilities
- Oversee clinical trial protocols from initiation to closure, ensuring FDA and ICH-GCP compliance
- Recruit, screen, and enroll eligible participants with precision and empathy
- Manage electronic data capture systems and maintain regulatory documentation
- Coordinate investigator meetings and prepare study reports for sponsor review
- Maintain 100% audit-ready trial documentation and site monitoring
- Liaise with IRB and ethics committees for protocol amendments and adverse event reporting
- Mentor junior staff and conduct SOP training for clinical teams
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- 3+ years of oncology clinical trial coordination experience
- Expertise in EDC systems (e.g., Medidata Rave) and regulatory documentation
- Demonstrated success in site activation and patient recruitment strategies
- Exceptional attention to detail and knowledge of 21 CFR Part 11 compliance
- Strong problem-solving skills with ability to navigate complex regulatory landscapes
- Excellent written communication for protocol development and reporting