Job Description
Join our pioneering medical research team at Global Health Innovations Institute, where we're transforming patient care through cutting-edge clinical trials. We seek a meticulous Senior Clinical Research Coordinator to drive complex oncology studies from protocol to publication. Work alongside world-renowned physicians in our state-of-the-art Boston facility, contributing to breakthrough treatments that impact lives globally.
Responsibilities
- Manage 5+ Phase II/III oncology clinical trials ensuring GCP/ICH compliance
- Oversee site activation, recruitment strategies, and patient enrollment targets
- Coordinate multidisciplinary teams including physicians, data managers, and regulatory affairs
- Monitor adverse events, maintain regulatory documentation, and prepare FDA submissions
- Implement eCRF systems and ensure data integrity across multiple platforms
- Present trial progress at steering committees and prepare FDA audit documentation
Qualifications
- Master's degree in Clinical Research, Nursing, or related health field
- 5+ years' experience in oncology clinical trials with 2+ leadership roles
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- Expertise in FDA regulations, ICH-GCP, and 21 CFR Part 11 compliance
- Advanced proficiency in clinical trial management systems (e.g., Medidata Rave)
- Strong data management experience with eCRF and EDC platforms
- Exceptional interpersonal skills for stakeholder management and patient advocacy