Job Description
Join Boston Medical Center's cutting-edge research division and transform healthcare innovation. We're seeking a Clinical Research Coordinator to spearhead groundbreaking studies that directly impact patient outcomes. In this pivotal role, you'll orchestrate complex clinical trials while ensuring regulatory compliance and data integrity. Collaborate with world-class physicians, industry partners, and regulatory bodies to advance medical breakthroughs. Your expertise will shape the future of evidence-based medicine while mentoring the next generation of research professionals.
BMC offers unparalleled career development, comprehensive benefits, and a supportive environment where your contributions directly impact patient care. If you're passionate about bridging research and clinical practice, this is your opportunity to thrive.
Responsibilities
- Design, implement, and manage Phase I-III clinical trials from protocol development to final report submission
- Recruit, screen, and enroll participants while maintaining strict adherence to inclusion/exclusion criteria
- Ensure compliance with FDA regulations, ICH-GCP standards, and institutional IRB protocols
- Oversee data collection, quality control, and statistical analysis using electronic data capture systems
- Liaise with pharmaceutical sponsors, CROs, and regulatory agencies for protocol amendments and submissions
- Train and mentor junior staff on SOPs, regulatory requirements, and study-specific procedures
- Prepare comprehensive study budgets, progress reports, and regulatory documentation
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field; Master's or PhD preferred
- 3+ years of clinical research coordination experience in an academic or hospital setting
- Certified Clinical Research Coordinator (CCRC) or equivalent certification required
- Expert knowledge of FDA regulations, ICH-GCP, and clinical trial methodologies
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical) and statistical software
- Demonstrated experience with regulatory submissions and audit preparation
- Exceptional organizational skills with ability to manage multiple concurrent studies
- Strong communication abilities for cross-functional collaboration with physicians, sponsors, and ethics committees