Novant Health - Winston-Salem, NC
posted about 2 months ago
Full-time - Entry Level
Winston-Salem, NC
Hospitals
About the position
The Clinical Research Regulatory Coordinator plays a crucial role in supporting investigators and research teams in conducting clinical trials. This position is responsible for managing regulatory and safety reporting processes across multiple studies, ensuring compliance with FDA regulations, Good Clinical Practice Guidelines, and institutional policies. The coordinator is dedicated to maintaining high standards of ethics, safety, quality, and compliance in clinical research.
Responsibilities
- Perform study-specific regulatory and safety reporting processes across multiple studies.
- Ensure compliance with FDA regulations, Good Clinical Practice Guidelines, and ICH Guidelines.
- Implement institutional review board policies and procedures.
- Coordinate various aspects of clinical trials to achieve desired outcomes.
- Foster a safe patient environment and promote teamwork and community involvement.
Requirements
- Minimum 5 years of clinical or clinical research experience required, with at least 2 years in clinical research.
- Minimum 8 years of clinical or clinical research experience required, with at least 5 years in clinical research and certification in Clinical Research.
- Proficient in Microsoft Office applications, Microsoft Teams, Zoom, Adobe Acrobat, and external portals used by clinical research business partners.
- Ability to read, understand, and implement institutional review board policies and procedures, Code of Federal Regulations, and Good Clinical Practice Guidelines.
- Understanding of medical terminology and project management skills.
Nice-to-haves
- Previous experience in a clinical research or healthcare setting such as lab, billing, coding, insurance, phlebotomy, pharmacy, or physician practices.
Benefits
- Diversity and inclusion initiatives
- Professional growth opportunities
- Teamwork and community involvement
