Clinical Research Source Document Specialist (Source Writer)

Advanced Research Institute • Ogden, UT, US • published 2026-09-21 22:42:50.121416

Description

**Job description:**The Source Document Specialist is responsible for developing, standardizing, and maintaining high\-quality source documentation used in clinical trials. They will create, edit, and manage study\-specific source documents based on trial protocols. This role ensures that source documents align with protocol requirements, regulatory standards, and site workflows to support accurate, complete, and audit\-ready data collection. **Responsibilities**: * Source Creation: Develop and design source documents based on study protocols, schedule of assessments, sponsor requirements, and other sponsor provided materials. * Protocol Translation: Analyze clinical protocols to develop clear, compliant source documents, worksheets, and templates for patient visits. * Version Control: Maintain and update source document templates for protocol amendments and process changes. * Quality Control (QC): Ensure all created documents adhere to \\(ICH/GCP\\) guidelines, FDA regulations, and sponsor requirements. * EDC Alignment: Structure source documents to align directly with Electronic Data Capture (EDC) systems to ensure high\-quality data collection. * Collaboration: Work with clinica...

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