Job Description
Join our award-winning team at MediCure Innovations, where we're pioneering breakthrough treatments in oncology and immunotherapy. We seek a Senior Clinical Research Coordinator to lead complex multi-center trials, ensuring regulatory compliance and data integrity while mentoring junior staff. This hybrid role offers competitive benefits, flexible scheduling, and opportunities for professional growth in Boston's vibrant healthcare ecosystem.
Responsibilities
- Oversee 5-10 clinical trial protocols from initiation to closeout
- Ensure FDA/ICH-GCP compliance and audit readiness
- Manage site relationships and investigator training
- Analyze trial data and prepare regulatory submissions
- Mentor 3+ junior coordinators in SOP implementation
- Coordinate with biostatisticians and ethics committees
- Implement EDC systems and risk-based monitoring
Qualifications
- Master's degree in clinical research, nursing, or life sciences
- 5+ years clinical trial coordination experience
- CRC or CCRA certification required
- Proficiency in Medidata Rave and Veeva Vault
- Strong knowledge of 21 CFR Part 11 and FDA regulations
- Experience with oncology therapeutic areas preferred
- Exceptional communication and problem-solving skills
- Ability to travel 20% of the time