Clinical Research Coordinator III

**About Denali Health:** Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities. **Position Summary:** The **Clinical Research Coordinator III (CRC III)** is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators. **Key Responsibilities:** - **Coordination of Clinical Trials:** - Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies. - **Study Management:** - Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders. - **Participant Coordination:** - Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants. - **Regulatory and Compliance Oversight:** - Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times. - **Data Management:** - Enter, review, and verify data in EDC systems and ensure timely query resolution. - **Team Coordination & Leadership:** - Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability. - **Communication & Reporting:** - Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes. **Qualifications:** - Bachelor’s degree in health sciences, nursing, or a related field (advanced degree preferred). - Minimum **3–5 years** of experience in clinical research coordination. - Strong understanding of GCP, ICH, and FDA regulations. - Exceptional coordination, multitasking, and communication skills. - Experience with EDC systems and clinical trial management software preferred. - CCRC/CCRP certification a plus. **Why Join Denali Health:** - Work with a mission-driven team advancing clinical research accessibility. - Competitive salary and comprehensive benefits package. - Professional growth and leadership opportunities. - Collaborative environment focused on innovation and patient care.