Clinical Research Regulatory Assistant

Position Summary:
We are seeking a highly organized and detail-oriented Regulatory Assistant to support regulatory operations at a busy independent clinical research site. This role is ideal for someone who enjoys administrative work, thrives in a structured environment, and has a strong interest in healthcare or clinical research.

Key Responsibilities:

• Prepare, organize, and maintain regulatory documents and study files (e.g., regulatory binders, essential documents)
• Assist with Institutional Review Board (IRB) submissions, amendments, and continuing reviews
• Ensure regulatory documents are complete, accurate, and audit-ready at all times
• Track document expiration dates (licenses, certifications, CVs, etc.)
• Support study start-up and close-out regulatory activities
• Maintain compliance with federal regulations, GCP guidelines, and sponsor requirements
• Communicate with study sponsors, CROs, and internal staff as needed
• Perform general administrative duties related to regulatory operations

Qualifications:

• High school diploma required
• Prior experience in a medical office, clinical research, or administrative role strongly preferred
• Basic understanding of medical terminology
• Exceptional attention to detail and organizational skills
• Ability to manage multiple tasks and meet deadlines
• Comfortable working with paperwork, electronic systems, and repetitive processes
• Proficient in Microsoft Office (Word, Excel, Outlook)

Work Environment:

• Office-based position with a strong focus on documentation and compliance
• Fast-paced environment with multiple ongoing studies

What We’re Looking For:

• Someone who takes pride in accuracy and organization
• A self-starter who can work independently once trained
• A team player who communicates clearly and professionally

Benefits

· Vacation and Sick Time

· Paid Holidays

Pay: $54,958.58 - $66,186.68 per year

Benefits:

• Paid time off
• Retirement plan

Work Location: In person