Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as we pioneer breakthrough treatments for cardiovascular diseases. We seek a meticulous Clinical Research Coordinator to orchestrate multi-center studies while ensuring compliance with FDA and ICH-GCP standards. This role offers the opportunity to directly impact patient outcomes and advance medical science in one of America's premier healthcare ecosystems.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials across 5+ sites
- Manage regulatory documentation including IRB submissions and FDA 1572 forms
- Train clinical staff on protocol adherence and data integrity protocols
- Analyze adverse event reports and prepare safety reports for FDA submissions
- Coordinate patient recruitment strategies achieving 95% enrollment targets
- Maintain electronic Case Report Forms (eCRFs) in Medidata Rave
- Liaise with CROs, sponsors, and ethics committees to ensure trial compliance
Qualifications
- Master's degree in Clinical Research, Nursing, or related health field
- 3+ years coordinating multi-site clinical trials in cardiology/oncology
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Expertise in FDA 21 CFR Part 812 and ICH-GCP guidelines
- Advanced proficiency in CTMS platforms (e.g., Veeva, Oracle)
- Strong data management skills with SAS or R experience
- Proven track record in achieving 95%+ patient retention rates
- Experience with central IRB submissions and electronic consenting systems