Clinical Trials Regulatory Specialist III

KEY RESPONSIBILITIES:

• Support all trial complexities and manage the study activation process.
• Serve as the internal project manager, providing timely updates on submissions and regulatory guidance.
• Liaison between the sponsor, the investigator, Winship, Emory IRBs, external IRBs and internal departments/staff.

DUTIES:

• Maintain study regulatory binders and electronic files.
• Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents are in place.
• Actively participate in designated committees within the unit and Emory University.

ADDITIONAL RESPONSIBILITIES:

• Perform internal audit and quality assurance checks on regulatory documents.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.