Denali Health · 2 months ago
Clinical Research Coordinator III
Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative clinical trials. The Clinical Research Coordinator III (CRC III) will lead the coordination and execution of complex clinical research studies, ensuring compliance with protocols and regulatory requirements while mentoring junior coordinators.
Research
Responsibilities
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
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
Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants
Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times
Enter, review, and verify data in EDC systems and ensure timely query resolution
Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability
Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes
Qualification
Required
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
Preferred
Experience with EDC systems and clinical trial management software preferred
CCRC/CCRP certification a plus
Benefits
Competitive salary and comprehensive benefits package.
Professional growth and leadership opportunities.
Collaborative environment focused on innovation and patient care.
Company
Denali Health
Denali Health is an Integrated Research Organization (IRO) dedicated to accelerating therapies from bench to market with integrity, quality, & innovation.
Funding
Current Stage
Early StageCompany data provided by crunchbase