Job Description
Join Boston Medical Center's prestigious research division where innovation meets compassionate care. We're seeking a Senior Clinical Research Coordinator to lead pivotal clinical trials that shape the future of medicine. In this role, you'll manage complex multi-center studies while mentoring junior staff and ensuring regulatory excellence. Our state-of-the-art facilities and collaborative environment provide unparalleled opportunities for professional growth in a mission-driven organization.
What We Offer:
- Comprehensive benefits package including health insurance, retirement plans, and paid time off
- Tuition reimbursement for advanced certifications
- Access to cutting-edge research technologies and methodologies
- Dynamic career development programs
Responsibilities
- Oversee end-to-end management of phase II-III clinical trials, ensuring protocol adherence and GCP compliance
- Recruit, screen, and enroll diverse patient populations while maintaining strict ethical standards
- Coordinate multi-site operations, including site initiation visits and monitoring visits
- Develop and maintain comprehensive regulatory documentation, including FDA submissions and IRB renewals
- Analyze and interpret complex clinical data, preparing interim analysis reports for stakeholders
- Mentor junior research staff and conduct training on regulatory requirements and study procedures
- Collaborate with biostatisticians and medical writers to prepare regulatory submissions and publications
Qualifications
- Master's degree in life sciences, nursing, or related field; PhD preferred
- Minimum 5 years of clinical research coordination experience with phase II-III trialsCertified Clinical Research Professional (CCRP) or equivalent certification
- Expert knowledge of FDA regulations, ICH-GCP guidelines, and 21 CFR Part 820
- Proven experience with EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong statistical literacy and experience with clinical data management
- Exceptional project management skills with ability to manage concurrent complex studies
- Demonstrated leadership experience in clinical research environments