Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials transforming patient care. We seek a passionate Senior Clinical Research Coordinator to drive groundbreaking studies in oncology and rare diseases. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of medicine in one of America's premier healthcare hubs.
Responsibilities
- Oversee end-to-end clinical trial management including protocol development, site activation, and regulatory compliance
- Lead cross-functional teams of physicians, data specialists, and regulatory affairs professionals
- Implement robust quality assurance protocols ensuring FDA/GCP adherence
- Analyze complex clinical data and generate actionable insights for study optimization
- Manage investigator relationships and site performance metrics
- Maintain electronic trial master files with 100% audit readiness
- Present findings to executive stakeholders and regulatory bodies
Qualifications
- Master's degree in Clinical Research, Nursing, or related health field
- 5+ years of clinical trial coordination experience in oncology or rare diseases
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA regulations, ICH-GCP, and 21 CFR compliance
- Advanced proficiency in CTMS platforms (e.g., Veeva, Medidata Rave)
- Exceptional project management with ability to manage concurrent multi-site trials
- Strong data analytics skills with experience in clinical statistical software
- Excellent communication and stakeholder management abilities