Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments for complex diseases. We seek a dynamic Senior Clinical Research Coordinator to orchestrate multi-center clinical trials, ensuring compliance with FDA regulations and ethical standards. This pivotal role bridges scientific innovation with patient care, driving life-changing therapies from lab to clinic. Enjoy competitive benefits, professional development, and the opportunity to shape the future of medicine.
Responsibilities
- Design and execute clinical trial protocols across 5+ sites
- Monitor site compliance with ICH-GCP guidelines and FDA regulations
- Manage electronic data capture systems and ensure data integrity
- Coordinate investigator meetings and regulatory submissions
- Oversee patient recruitment strategies and retention protocols
- Prepare FDA submissions and audit responses
- Mentor junior staff and optimize trial workflows
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) required
- Expertise in oncology or rare disease trials preferred
- Proficiency in Medidata Rave and Oracle CTMS
- Strong knowledge of 21 CFR Parts 11, 312, and 812
- Exceptional project management and stakeholder communication skills
- Experience managing $5M+ clinical trial budgets