Description
Position: Part-Time Remote Regulatory Document Specialist
Hours: 20 hours per week
We need someone who knows how to manage regulatory documents and maintain a clean and organized eISF!
CRIO experience necessary.
Oncology experience highly preferred.
Responsibilities
• Maintain and organize the Investigator Site File (ISF) for all active and archived clinical trials in accordance with ICH E6(R3) GCP guidelines
• Manage and maintain site regulatory documents within the CRIO eRegulatory platform, ensuring all records are current, complete, and inspection-ready at all times
• Collect, track, and file essential regulatory documents including FDA Forms 1572, financial disclosure forms, protocol amendments, IRB approvals, and sponsor correspondence — all managed remotely via electronic platforms
• Coordinate with the IRB for initial submissions, continuing reviews, amendments, and safety reports; track submission and approval deadlines independently...