Regulatory Affairs Assistant

Job Summary

A company is looking for a Regulatory Affairs Assistant (Remote).

Key Responsibilities

• Maintain the Investigator Site File (ISF) for assigned studies, including IRB submissions and approvals
• Create and update Delegation of Authority Logs and ensure log review and finalization at study close-out
• Handle monitor visits and manage the filing of training documentation in the ISF

Required Qualifications

• High school diploma or equivalent
• Proficient working knowledge of Microsoft Word
• Strong organizational skills with a sense of timeliness in completing projects
• Detail-oriented with good spelling, composition, and proofreading skills
• Ability to complete tasks with minimal supervision and understand instructions