Regulatory Document Specialist

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 submissi...