Job Description
Join our pioneering team at MedTech Innovations, where cutting-edge research meets transformative patient care. We're seeking a Senior Clinical Research Coordinator to drive our next-generation oncology trials forward. This role offers the opportunity to work with world-class researchers and directly impact medical breakthroughs in a collaborative, innovation-driven environment. Enjoy competitive benefits, professional development stipends, and the chance to shape the future of healthcare.
Responsibilities
- Oversee end-to-end management of Phase I-III clinical trials, ensuring protocol adherence and regulatory compliance
- Lead recruitment strategies and maintain relationships with 15+ key research sites across the Northeast
- Implement electronic data capture systems and conduct rigorous quality control audits
- Coordinate interdisciplinary teams including physicians, biostatisticians, and regulatory affairs specialists
- Develop comprehensive trial documentation including IBs, informed consent forms, and study reports
- Analyze adverse event data and prepare FDA submissions with 100% accuracy
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience in oncology or rare disease
- Current ACRP or SOCRA certification with ongoing CME credits
- Advanced proficiency in Medidata Rave and CTMS platforms
- Demonstrated success managing multi-center trials with budgets exceeding $5M
- Expert knowledge of ICH-GCP, FDA 21 CFR Part 312, and international regulatory frameworks
- Certified Clinical Research Professional (CCRP) preferred