Job Description
Join MedCore Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough therapies to transform patient care. We seek a passionate Senior Clinical Research Coordinator to oversee complex clinical trials while maintaining the highest standards of regulatory compliance and data integrity. This role offers the opportunity to work with renowned physicians and contribute to life-changing medical advancements in our state-of-the-art Boston facility.
Responsibilities
- Design, implement, and manage multi-phase clinical trials from protocol development to final reporting
- Ensure strict adherence to FDA regulations, GCP guidelines, and institutional review board protocols
- Coordinate investigator meetings, site visits, and cross-functional team communications
- Oversee data collection, quality control, and statistical analysis preparation
- Maintain accurate trial documentation in electronic data capture systems
- Monitor patient recruitment progress and retention strategies
- Lead risk-based monitoring and audit preparation activities
Qualifications
- Master's degree in Clinical Research, Nursing, or related health sciences with 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Expert knowledge of ICH-GCP, FDA 21 CFR Part 312, and clinical trial regulations
- Proven experience managing Phase II-III trials in oncology or immunology
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional project management skills with ability to manage multiple concurrent trials
- Strong analytical skills with experience in statistical reporting and data interpretation