Job Description
Join our cutting-edge medical research team at MedTech Innovations, where we pioneer breakthrough treatments in oncology and rare diseases. As a Clinical Research Coordinator, you'll drive pivotal clinical trials while ensuring regulatory compliance and patient safety. We offer competitive benefits, professional development stipends, and a collaborative environment where your expertise directly impacts patient outcomes.
Responsibilities
- Oversee end-to-end clinical trial management from protocol design to FDA submission
- Recruit and retain diverse patient cohorts while maintaining strict GCP standards
- Monitor data integrity and conduct site audits for 15+ active studies
- Liaise with IRB, sponsors, and regulatory bodies for compliance documentation
- Mentor junior staff and implement process improvements using ePRO systems
- Analyze adverse event reports and prepare safety reports for DSMB review
Qualifications
- Master's degree in Nursing, Public Health, or Clinical Research with 3+ years' CRC experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Expertise in oncology trial protocols (CTCAE v5) and EDC systems (e.g., Medidata Rave)
- Proven track record in FDA 1572 and ICH-GCP compliance documentation
- Advanced knowledge of HIPAA privacy regulations and electronic consent processes
- Experience with vendor management and multi-site trial coordination
- Exceptional problem-solving skills with complex regulatory scenarios