Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments for rare diseases. We seek a passionate Senior Clinical Research Coordinator to oversee multi-center trials in our oncology division. You'll work directly with world-class physicians, regulatory experts, and pharmaceutical partners to ensure protocol integrity and patient safety. Enjoy competitive benefits, flexible scheduling, and opportunities to present findings at international conferences.
Responsibilities
- Design and implement clinical trial protocols in compliance with FDA/ICH-GCP standards
- Recruit and screen patients while maintaining strict ethical protocols
- Monitor data integrity and resolve discrepancies in electronic health records
- Coordinate cross-functional teams including biostatisticians and regulatory affairs
- Prepare regulatory submissions and ensure audit readiness
- Train junior staff on clinical trial procedures and documentation
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 3+ years coordinating oncology/hematology trials
- Certified Clinical Research Professional (CCRP) required
- Experience with Medidata Rave and Oracle Clinical
- Proven track record in FDA audit compliance
- Exceptional attention to detail and documentation skills
- Strong knowledge of HIPAA and 21 CFR Part 11