Regulatory Assistant - Clinical Trials Office

📋 Description

• • Provides regulatory support to ensure clinical research protocols comply with university, state, and federal regulations across teams managed by the Clinical Trials Office.
• • Assists in preparing and submitting protocol documentation to Institutional Review Boards (IRBs) and tracks submission status updates.
• • Prepares and maintains other required regulatory documents necessary for clinical trial compliance.
• • Distributes approved regulatory documents to relevant clinical research staff and departments.
• • Communicates regulatory updates and requirements to clinical research personnel to ensure ongoing compliance.
• • Performs data entry tasks including collecting, entering, and maintaining regulatory and trial data in the OnCore electronic database.
• • Supports monitoring visits by preparing materials and ensuring regulatory documentation is current and accessible.
• • Assists in resolving regulatory issues that arise during clinical trial execution.
• • Creates, organizes, and maintains comprehensive regulatory files for clinical trials in accordance with institutional standards.
• • Collaborates with clinical research teams to ensure all regulatory activities are completed accurately and on time.
• • Supports the Clinical Trials Office in maintaining audit-ready documentation for internal and external reviews.
• • Ensures all regulatory processes align with Good Clinical Practice (GCP) guidelines and applicable federal regulations.
• • Works closely with research staff to facilitate timely IRB approvals and renewals.
• • Maintains accurate records of regulatory correspondence, approvals, and amendments related to active clinical trials.
• • Participates in training and process improvement initiatives to enhance regulatory workflow efficiency.