Job Description
Join our cutting-edge clinical research team at Boston Medical Innovations, where we're pioneering breakthrough treatments in oncology and immunotherapy. We seek a passionate Senior Clinical Research Coordinator to manage complex clinical trials and ensure regulatory compliance while driving innovation in patient care.
As a leader in medical research, we offer competitive benefits, professional development opportunities, and a collaborative environment where your expertise directly impacts patient outcomes. Our state-of-the-art facilities are located in Boston's renowned Longwood Medical Area.
Responsibilities
- Oversee end-to-end management of Phase II-III clinical trials, including protocol development, site selection, and patient recruitment
- Ensure strict adherence to FDA regulations, GCP standards, and institutional IRB protocols
- Coordinate multidisciplinary teams including physicians, data managers, and biostatisticians
- Monitor adverse events and implement risk mitigation strategies
- Prepare regulatory submissions and maintain comprehensive trial documentation
- Analyze clinical data and contribute to publication-ready manuscripts
- Mentor junior staff and optimize clinical trial workflows
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field (or equivalent experience)
- 5+ years of clinical research coordination experience in oncology/immunology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA regulations, ICH-GCP, and 21 CFR compliance
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Exceptional project management skills with ability to manage multiple complex protocols
- Strong analytical skills for data interpretation and report generation
- Excellent written/verbal communication and leadership abilities