Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and lead transformative healthcare initiatives. We're pioneering next-generation clinical trials in oncology and rare diseases, and we need your expertise to ensure compliance, efficiency, and patient safety. This role offers the opportunity to work with world-class researchers while advancing medical breakthroughs that impact global health.
Responsibilities
- Oversee end-to-end clinical trial execution, ensuring protocol adherence and FDA/GCP compliance
- Manage complex patient recruitment strategies and retention programs for diverse cohorts
- Coordinate cross-functional teams including investigators, sponsors, and regulatory bodies
- Maintain meticulous documentation of trial data, adverse events, and regulatory submissions
- Implement risk-based monitoring protocols and quality assurance processes
- Lead site initiation visits and routine audits for multiple concurrent trials
- Develop and maintain electronic data capture systems for real-time trial oversight
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical trial coordination experience in oncology or rare diseases
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA regulations, ICH-GCP, and 21 CFR Part 820
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated success in managing multi-site international trials
- Strong data analysis skills with SAS or R programming experience
- Exceptional leadership abilities with 3+ years mentoring junior staff