Regulatory Data Coordinator for Investigator Trials

University System of Georgia; Georgia; On-site; USD 39,000 - 42,000; Full time

Job summary

Augusta University in Augusta, GA, is seeking a regulatory support professional for investigator-initiated trials within the GCC CTO. The role assists with IRB submissions, FDA reporting, and SIV preparation, ensuring compliance with federal, state, and local regulations.

Candidates will coordinate IRB forms, provide meeting facilitation support, manage OnCore access, and perform additional duties to support study teams in a fast-paced research environment.

Qualifications

• Associate's degree in a related field.
• Two years of college + two years related work experience.

Responsibilities

• IRB submission support for local IRB and regulatory forms.
• SIV meeting facilitation and FDA annual report support.
• Provide access and data coordination in OnCore for study teams.
• Perform additional duties as assigned.

Skills

Confidentiality

Attention to detail

Communication skills

Microsoft Office

Time management

Education

Associate's degree in a related field

Two years of college + two years related work experience

Tools

OnCore

Job description

Augusta University in Augusta, GA, is seeking a regulatory support professional for investigator-initiated trials within the GCC CTO. The role assists with IRB submissions, FDA reporting, and SIV preparation, ensuring compliance with federal, state, and local regulations.

Candidates will coordinate IRB forms, provide meeting facilitation support, manage OnCore access, and perform additional duties to support study teams in a fast-paced research environment.