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.