Job Description
Join our pioneering team at MediGen Innovations, where we're transforming healthcare through groundbreaking clinical trials. We seek a Senior Clinical Research Coordinator to lead complex oncology studies at our state-of-the-art Boston facility. You'll be at the forefront of medical innovation, collaborating with top-tier physicians and biotech experts to accelerate life-saving treatments.
As a key member of our Clinical Operations division, you'll ensure regulatory compliance while driving protocol execution excellence. Our competitive package includes comprehensive health benefits, professional development stipends, and flexible work arrangements. Discover your next career milestone with an organization ranked among Boston's Top 10 Healthcare Employers.
Responsibilities
- Oversee end-to-end management of Phase II-III oncology clinical trials, including site selection, initiation, and closeout
- Ensure 100% compliance with FDA regulations, ICH-GCP guidelines, and institutional protocols
- Lead cross-functional collaboration between biostatisticians, data managers, and regulatory affairs teams
- Implement risk-based monitoring strategies and conduct quality control audits
- Develop comprehensive trial budgets and manage vendor relationships
- Mentor junior coordinators and train staff on emerging regulatory requirements
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of oncology clinical trial coordination experience with at least 2 years in leadership
- Certified Clinical Research Professional (CCRP) or ACRP certification
- Demonstrated expertise in FDA 21 CFR Part 11 and electronic data capture systems
- Proven track record of managing multi-center trials with 15+ investigational sites
- Exceptional problem-solving skills in complex regulatory environments
- Proficiency in clinical trial management software (e.g., Medidata Rave, Veeva Vault)