Regulatory Operations Specialist — Clinical Trials

St. Joseph's/Candler; Savannah (GA); On-site; USD 65,000 - 85,000; Full time

Job summary

St. Joseph's/Candler in Savannah, GA, seeks a Research Regulatory Specialist to support the regulatory department and ensure GCP, DHHS, and FDA guideline compliance.

The role handles regulatory documentation, IRB/sponsor review preparation, and coordination of monitoring visits, with emphasis on accuracy and timely reporting. Strong organizational skills and familiarity with CREDIT and Florence are valued.

Qualifications

• Associate's Degree required; Bachelor's preferred.
• 1-2 years of general healthcare or legal experience preferred.
• GCP and Human Protections Training preferred.

Responsibilities

• Assist in maintaining regulatory master files for each clinical trial and assist in preparing documents for IRB and/or sponsor review.
• Ensure all study specific Financial Disclosure Forms (FDFs), annual FDFs and safety reports are prepared, filed, completed, and submitted accurately in a timely manner.
• Maintain research staff trainings and credentialing using a tracking system.
• Coordinate various forms of communication, including phone and email, and respond to Regulatory & Compliance Manager and Regulatory Coordinator; manage documents per clinical trial requirements.
• Maintain historical and current documents for clinical trials utilizing CREDIT & Florence software; update LCRP and GA CORE websites to ensure active trials are visible.

Skills

Regulatory documentation

Regulatory compliance

Documentation management

Communication

Education

Associate's Degree

Bachelor's Degree

Tools

CREDIT

Florence

Job description

St. Joseph's/Candler in Savannah, GA, seeks a Research Regulatory Specialist to support the regulatory department and ensure GCP, DHHS, and FDA guideline compliance.

The role handles regulatory documentation, IRB/sponsor review preparation, and coordination of monitoring visits, with emphasis on accuracy and timely reporting. Strong organizational skills and familiarity with CREDIT and Florence are valued.