Job Description
Join Boston's premier medical research institution at the forefront of innovative healthcare solutions. We're seeking a passionate Senior Clinical Research Coordinator to lead groundbreaking studies that transform patient outcomes. Collaborate with world-class physicians and scientists in a dynamic, cutting-edge environment where your expertise directly impacts medical advancements.
Our institute offers competitive compensation, comprehensive benefits, and unparalleled professional development opportunities. Shape the future of medicine while working with state-of-the-art facilities and a multidisciplinary team dedicated to excellence.
Responsibilities
- Design, implement, and monitor complex clinical trial protocols ensuring compliance with FDA and GCP standards
- Recruit, screen, and enroll participants while maintaining accurate patient records and informed consent documentation
- Coordinate multi-site research activities including data collection, lab specimen handling, and regulatory submissions
- Analyze and interpret clinical data using statistical software to generate comprehensive study reports
- Maintain regulatory documentation and prepare FDA submissions with meticulous attention to detail
- Mentor junior staff and conduct site visits to ensure protocol adherence across all research facilities
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical research coordination experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA regulations, ICH-GCP guidelines, and 21 CFR compliance
- Proficient in electronic data capture systems (e.g., Medidata Rave) and statistical software
- Demonstrated ability to manage complex multi-center trials with diverse patient populations
- Exceptional communication skills with experience presenting findings to regulatory bodies