Job Description
Join our pioneering team at Massachusetts General Hospital and drive transformative medical research. We seek a Senior Clinical Research Coordinator to oversee complex clinical trials, ensuring adherence to FDA regulations and ethical standards. You'll collaborate with interdisciplinary teams, manage patient recruitment, and contribute to breakthrough treatments that shape global healthcare.
Responsibilities
- Design and implement clinical trial protocols in compliance with ICH-GCP guidelines
- Coordinate multi-center studies, including site selection, initiation, and monitoring
- Manage electronic data capture systems and ensure data integrity
- Liaise with IRB and regulatory bodies for protocol amendments and adverse event reporting
- Mentor junior staff and conduct training on regulatory compliance
- Present findings at scientific conferences and contribute to peer-reviewed publications
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 5+ years of clinical trial coordination experience in oncology or rare diseases
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in electronic data capture systems (e.g., Medidata Rave)
- Demonstrated success in managing FDA audits and inspections
- Strong expertise in biostatistics and clinical trial design methodologies
- Exceptional communication skills for stakeholder engagement and patient advocacy