Job Description
Join our award-winning medical research team at Boston Medical Innovations, where we're pioneering breakthrough treatments in oncology and rare diseases. As a Senior Clinical Research Coordinator, you'll lead pivotal trials that transform patient outcomes while working in our state-of-the-art facility near Longwood Medical Area. We offer competitive compensation, comprehensive benefits, and a collaborative environment dedicated to scientific excellence.
Responsibilities
- Design and execute complex clinical trial protocols ensuring FDA/ICH/GCP compliance
- Manage site operations including patient recruitment, enrollment, and retention strategies
- Serve as primary liaison between investigators, sponsors, and regulatory bodies
- Analyze and interpret trial data using advanced statistical software tools
- Maintain meticulous electronic and paper trial documentation systems
- Lead cross-functional teams including data managers, biostatisticians, and regulatory affairs
- Develop training materials and mentor junior research coordinators
Qualifications
- Master's degree in Life Sciences, Nursing, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record managing phase II-III oncology or rare disease trials
- Expertise in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Strong knowledge of FDA regulations, ICH-GCP, and 21 CFR Part 11
- Exceptional project management skills with ability to handle multiple concurrent trials
- Excellent written and verbal communication skills for stakeholder reporting
- Experience with budget preparation and financial trial management