Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments for rare diseases. We're seeking a meticulous Clinical Research Coordinator to drive our next-generation clinical trials. This role offers unparalleled opportunity to work with world-class physicians and directly impact patient outcomes in our state-of-the-art facilities.
Why Join Us?
- Collaborate with Nobel Prize-winning researchers
- Access to industry-leading training and professional development
- Comprehensive benefits package including malpractice insurance
- Dynamic, mission-driven work environment
Responsibilities
- Oversee clinical trial protocols ensuring compliance with FDA regulations and GCP standards
- Coordinate patient recruitment, screening, and enrollment processes
- Manage electronic data capture systems and maintain accurate regulatory documentation
- Liaise between investigators, sponsors, and IRB to resolve protocol deviations
- Analyze and report adverse events and safety data to regulatory authorities
- Train clinical staff on trial-specific procedures and documentation requirements
- Prepare interim/final study reports for FDA submissions and publications
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences (BSN with 3+ years experience considered)
- CCRA or SOCRA certification required (ACRP preferred)
- Minimum 3 years clinical trial coordination experience in therapeutic areas
- Expertise in EDC systems (Medidata Rave, Oracle Inform) and CTMS platforms
- Demonstrated knowledge of ICH-GCP, FDA 21 CFR Part 812, and HIPAA regulations
- Exceptional attention to detail with proven audit success rate
- Strong interpersonal skills for multi-stakeholder communication