Job Description
Join our pioneering team at MediCore Innovations, where cutting-edge medical research meets compassionate patient care. We seek a dynamic Senior Clinical Research Coordinator to drive transformative clinical trials in oncology and immunotherapy. This pivotal role bridges scientific innovation with real-world application, ensuring our breakthrough therapies reach patients safely and efficiently. Collaborate with world-class physicians, regulatory experts, and biotechnology partners in Boston's premier healthcare ecosystem. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of medicine.
Responsibilities
- Design and implement comprehensive clinical trial protocols in compliance with FDA and ICH-GCP standards
- Oversee site management, including IRB submissions, regulatory documentation, and vendor coordination
- Lead data integrity initiatives through EDC system management and source data verification
- Mentor junior staff and conduct investigator meetings to ensure protocol adherence
- Analyze trial data and prepare comprehensive reports for FDA submissions and internal stakeholders
- Develop risk mitigation strategies for complex multi-center oncology trials
Qualifications
- Master's degree in Clinical Research, Nursing, or related healthcare field (PhD preferred)
- 5+ years of clinical trial coordination experience in oncology/immunotherapy
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Demonstrated success in managing Phase II-III oncology trials with 15+ sites
- Expertise in FDA regulatory submissions and audit preparation
- Strong leadership skills with experience mentoring cross-functional teams