Clinical Research Regulatory Coordinator

Novant Health - Charlotte, NC

Full-time - Entry Level

Charlotte, NC

Hospitals

About the position

The Clinical Research Regulatory Coordinator at Novant Health 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 policies and Standard Operating Procedures (SOPs).
• Support investigators and research teams in conducting clinical trials.
• Foster a safe patient environment driven by the principles of 'First Do No Harm'.
• Engage in teamwork and community involvement to enhance patient care.

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, Good Clinical Practice Guidelines, ICH guidelines, and standard operating procedures.
• Understanding of medical terminology.
• Strong planning and coordination skills to manage multiple tasks effectively.
• Project and time management skills.
• Advanced computer skills.

Nice-to-haves

• Previous experience in clinical research or healthcare settings such as lab, billing, coding, insurance, phlebotomy, pharmacy, or physician practices.