Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and lead groundbreaking studies that transform patient care. We're seeking a passionate professional to manage complex clinical trials in our state-of-the-art research facility. Collaborate with multidisciplinary teams, ensure regulatory compliance, and contribute to life-changing medical innovations.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to final report submission
- Monitor patient recruitment, enrollment, and retention across multiple study sites
- Ensure strict adherence to FDA regulations, GCP guidelines, and institutional protocols
- Manage electronic data capture systems and maintain accurate trial documentation
- Coordinate with investigators, sponsors, and ethics committees for seamless trial operations
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Mentor junior coordinators and optimize research workflows
Qualifications
- Master's degree in Clinical Research, Nursing, or related health sciences
- 5+ years of clinical trial coordination experience in therapeutic areas (oncology preferred)
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Proven expertise in EDC systems (e.g., Medidata Rave, Oracle Clintrial)
- Exceptional knowledge of ICH-GCP and FDA 21 CFR Part 11 regulations
- Strong data analysis skills with proficiency in statistical software (SPSS, SAS)
- Excellent communication abilities for stakeholder management and training
- Experience managing multi-center studies with 50+ participants