Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and drive groundbreaking medical research initiatives. We're seeking a meticulous professional to oversee complex clinical trials, ensuring compliance with FDA regulations and ethical standards. This role offers unparalleled opportunities to shape the future of healthcare while working with world-class researchers in state-of-the-art facilities.
Responsibilities
- Design, implement, and manage multi-site clinical trials from protocol to closeout
- Ensure GCP compliance and regulatory documentation accuracy
- Recruit and screen participants while maintaining ethical trial standards
- Analyze trial data and prepare comprehensive regulatory submissions
- Coordinate cross-functional teams including physicians, statisticians, and sponsors
- Monitor adverse events and ensure patient safety protocols
- Present findings to institutional review boards and stakeholders
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences
- 5+ years of clinical trial coordination experience in therapeutic areas
- Certified Clinical Research Professional (CCRP) required
- Expertise in FDA 21 CFR Part 312 and ICH-GCP guidelines
- Proficiency with electronic data capture systems (e.g., Medidata Rave)
- Exceptional attention to detail and documentation skills
- Strong project management and stakeholder communication abilities