Regulatory Affairs Assistant

Regulatory Affairs Assistant

Location: Fully onsite

Join our client's clinical research team as a Regulatory Affairs Assistant, where you'll play a key role in keeping studies compliant, organized, and audit-ready. This is a fully onsite position and a great opportunity for a detail-oriented professional to grow within a fast-paced research environment - no prior clinical research experience required, just a strong work ethic and a sharp eye for accuracy.

What You'll Do

A general understanding of GCP/ICH guidelines is expected. Day to day, you will:

• Collect and prepare regulatory documents for submission to the sponsor and IRB
• Maintain current regulatory documents, including CVs, licenses, and required training records
• Set up the electronic Investigator Site File (ISF) for all awarded studies
• Obtain signatures on regulatory documents as needed
• Keep study logs up to date, such as Screening and Enrollment Logs and Training Logs
• File study-related correspondence (sponsor, IRB, etc.) in the Investigator Site File
• Support the resolution of regulatory items identified during monitoring visits
• Maintain current training on applicable SOPs/WIs, GCP, and related requirements
• Archive study documents following study closure

What You'll Bring

Education and Experience

• High school diploma or equivalent; two-year degree preferred
• Clinical research experience preferred but not required

Requirements

• Working knowledge of medical terminology and the clinical research process
• Strong attention to detail
• Solid organizational skills
• Strong computer skills, including proficiency across all Microsoft Office applications