Job Description
Join our pioneering research team at MediTech Innovations, where we're transforming patient care through groundbreaking clinical trials. As a Senior Clinical Research Coordinator, you'll lead complex studies in our state-of-the-art Boston facility, collaborating with world-class physicians and biotech innovators. We offer a dynamic environment with cutting-edge resources and opportunities for professional growth in the rapidly evolving field of medical research.
Responsibilities
- Design and oversee implementation of multi-center clinical trials from protocol development to closeout
- Recruit, screen, and enroll qualified participants while ensuring strict protocol adherence
- Manage electronic data capture systems and maintain comprehensive regulatory documentation
- Coordinate with IRB submissions and ensure compliance with FDA/ICH-GCP guidelines
- Analyze trial data and prepare comprehensive study reports for regulatory submissions
- Mentor junior research staff and conduct site monitoring visits
- Liaise with pharmaceutical sponsors and CRO partners on trial progress
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience with oncology focus
- Certified Clinical Research Professional (CCRP) certification required
- Proven expertise in FDA/ICH-GCP and 21 CFR Part 11 compliance
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional project management and multitasking abilities
- Strong analytical skills with experience in statistical data interpretation
- Excellent communication skills with cross-functional teams