Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and drive groundbreaking medical research that transforms patient care. We're seeking a detail-oriented professional to oversee complex clinical trials in our state-of-the-art research facility. You'll collaborate with leading physicians, biotech partners, and regulatory bodies to ensure studies meet rigorous scientific and ethical standards. This role offers competitive compensation, comprehensive benefits, and the opportunity to contribute to life-saving innovations in cardiology and oncology research.
Responsibilities
- Design and implement clinical trial protocols ensuring FDA and ICH-GCP compliance
- Recruit, screen, and enroll qualified participants while maintaining strict ethical standards
- Manage complex data collection systems and maintain accurate electronic trial records
- Liaise with IRB and regulatory agencies for protocol amendments and reporting
- Train and mentor junior research staff on SOPs and regulatory requirements
- Analyze trial data and prepare comprehensive reports for stakeholders
- Coordinate multidisciplinary teams including physicians, statisticians, and lab technicians
Qualifications
- Master's degree in Clinical Research, Nursing, or related life science field
- 5+ years of clinical trial coordination experience in cardiology/oncology
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Demonstrated experience with FDA audits and regulatory documentation
- Strong knowledge of ICH-GCP and 21 CFR Part 11 compliance
- Exceptional organizational skills with ability to manage multiple complex protocols
- Excellent written communication for preparing regulatory submissions and reports