Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments in oncology and rare diseases. We seek a meticulous Clinical Research Coordinator to orchestrate multi-center trials, ensuring protocol adherence and regulatory compliance. Collaborate with world-class physicians, biostatisticians, and pharmaceutical partners to accelerate therapeutic innovation. Enjoy competitive benefits, flexible scheduling, and opportunities for professional growth in our state-of-the-art facilities.
Responsibilities
- Design, implement, and monitor clinical trial protocols across 5+ research sites
- Recruit, screen, and enroll 50+ eligible patients monthly while maintaining strict IRB compliance
- Manage electronic data capture systems (EDC) and ensure 99% data accuracy
- Coordinate FDA submissions, adverse event reporting, and site audits
- Mentor junior staff and conduct investigator meetings for protocol optimization
- Analyze interim data and prepare regulatory submissions for FDA/EMA approval
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 3+ years' experience in oncology/rare disease clinical trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA regulations (21 CFR Part 312) and ICH-GCP guidelines
- Advanced proficiency in Medidata Rave and Oracle Clinical
- Strong statistical knowledge for interim analysis interpretation
- Proven track record in patient retention >85% across complex trials