Clinical Trial Documentation Associate

Job Summary

Supporting clinical trial operations, the full-time remote Trial Documentation Associate I will manage regulatory document collection, review, organization, and maintenance throughout the study lifecycle, ensuring compliance and inspection readiness.

Key responsibilities:

• Provide ongoing assistance for clinical research operations, including study documentation maintenance and monitoring reports
• Collect, review, and maintain essential regulatory documents while activating new and amended protocols at an institutional level
• Track and update documentation, study status, and key milestones within CTMS, eTMF, and other systems as needed

Required qualifications:

• Bachelor's degree in a relevant area
• Prior experience with clinical research operations preferred
• Proficiency in Trial Master File (TMF/eTMF) setup and maintenance strongly preferred
• Working knowledge of ICH/GCP guidelines preferred
• Prior experience in study start-up and site management preferred