Regulatory Affairs Administrative Assistant

Job Summary

A company is looking for an Administrative Assistant - Regulatory Affairs to maintain regulatory documentation for investigational drug studies.

Key Responsibilities

• Maintain the Investigator Site File (ISF) for assigned studies, including IRB submissions and approvals
• Manage documentation and obtain Investigator signatures for study-specific documents
• Handle monitor visits and manage training documentation for study staff

Required Qualifications

• High school diploma or equivalent
• Proficient working knowledge of Microsoft Word
• Strong organizational skills and ability to complete tasks with minimal supervision
• Detail-oriented with good spelling, composition, and proofreading skills
• Ability to understand instructions and compose reports and correspondence