Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as we pioneer breakthrough therapies in oncology and rare diseases. We're seeking a passionate Senior Clinical Research Coordinator to drive our mission of transforming patient outcomes through rigorous scientific excellence. This hybrid role offers the opportunity to shape the future of medicine while working with world-class researchers in Boston's prestigious Longwood Medical Area.
Responsibilities
- Design and execute complex clinical trial protocols ensuring FDA/EU regulatory compliance
- Manage site initiation, monitoring, and closeout activities across multi-center studies
- Oversee data integrity through EDC systems and source document verification
- Liaise with IRBs, ethics committees, and regulatory agencies
- Mentor junior CRCs and conduct staff training on GCP standards
- Develop patient recruitment strategies and maintain diverse participant cohorts
- Coordinate investigator meetings and prepare regulatory submissions
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience in oncology/rare diseases
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in ICH-GCP, FDA 21 CFR, and EMA guidelines
- Advanced proficiency in Medidata Rave and Oracle Clinical
- Proven track record in site activation and patient recruitment
- Exceptional project management and stakeholder communication skills
- Experience with rare disease trial methodologies preferred