Job Description
Join our pioneering medical research team at MediGen Innovations, where cutting-edge science meets compassionate care. We're seeking a Clinical Research Coordinator to drive transformative studies in oncology and rare diseases. Enjoy competitive compensation, comprehensive benefits, and a collaborative environment at our state-of-the-art Boston facility. Shape the future of medicine while advancing your career in a role that truly makes a difference.
Responsibilities
- Oversee clinical trial protocols including IRB submissions, patient recruitment, and data management
- Coordinate multi-disciplinary research teams and external vendor relationships
- Ensure strict compliance with FDA regulations and Good Clinical Practice (GCP) standards
- Monitor patient safety and adverse event reporting throughout study phases
- Prepare regulatory documents, study reports, and trial publications
- Implement electronic data capture systems and maintain accurate trial documentation
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related medical field (Master's preferred)
- 3+ years clinical research coordination experience with oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Demonstrated knowledge of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Exceptional organizational skills with attention to regulatory detail
- Strong interpersonal abilities for patient and stakeholder communication