Clinical Research Coordinator III - Denali Health : Job Details

About the Role

We are seeking an experienced Clinical Research Coordinator III (CRC III) to join our growing clinical research team. The CRC III will play a pivotal role in the planning, execution, and oversight of clinical trials, ensuring compliance with regulatory requirements, Good Clinical Practice (GCP), and internal quality standards. This position is ideal for a highly organized professional with proven leadership in clinical trial coordination who is eager to contribute to advancing clinical research.

Key Responsibilities

• Serve as the primary coordinator for complex Phase I–IV clinical trials, including sponsor- and investigator-initiated studies.
• Lead study start-up activities: feasibility, site initiation, IRB submissions, and regulatory documentation.
• Oversee subject recruitment, screening, informed consent, and enrollment.
• Manage all aspects of study visits, including assessments, data collection, and reporting.
• Ensure accurate and timely data entry, query resolution, and maintenance of study records in compliance with GCP and protocol requirements.
• Train, mentor, and support junior coordinators (CRC I/II) and research staff.
• Act as a key liaison with sponsors, CROs, investigators, and study monitors.
• Support audits and inspections by regulatory authorities and sponsors.
• Contribute to the continuous improvement of site operations and best practices.

Qualifications

• Bachelor's degree in a health-related field (nursing, life sciences, or equivalent required; advanced degree preferred).
• Minimum 2 years in a research role.
• Strong understanding of FDA, ICH, and GCP guidelines.
• Proven ability to manage multiple clinical studies simultaneously.
• Excellent organizational, communication, and leadership skills.
• Proficiency with EDC systems, CTMS platforms, and Microsoft Office Suite.
• Certification in Clinical Research (CCRC, CCRP, or equivalent) preferred.

Why Join Us

• Opportunity to work on impactful clinical trials that shape the future of healthcare.
• Collaborative, mission-driven team with growth opportunities.
• Competitive salary and comprehensive benefits package.

Please Email [email protected] your resume and cover letter for review.