Job Description
Join our pioneering team at MediCore Innovations, where we're revolutionizing patient care through groundbreaking clinical trials. As a Senior Clinical Research Coordinator, you'll lead the execution of Phase II-III oncology studies, ensuring regulatory compliance while mentoring junior staff. Enjoy a collaborative environment with cutting-edge resources and opportunities for professional growth in Boston's vibrant healthcare ecosystem.
Responsibilities
- Oversee end-to-end management of multi-center oncology clinical trials
- Ensure strict adherence to FDA, ICH-GCP, and protocol requirements
- Lead site initiation, monitoring, and closeout activities
- Mentor 3+ junior coordinators through training and performance feedback
- Develop and maintain comprehensive regulatory documentation
- Analyze clinical data and prepare FDA submission-ready reports
- Collaborate with biostatisticians on protocol design amendments
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of oncology clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) certification required
- Proven track record with FDA audits and 1572 submissions
- Expertise in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Strong leadership skills with team management experience
- Excellent written communication for protocol development
- Experience with rare disease trials preferred