Source Document Specialist

Job Summary

A company is looking for a Source Document Specialist who will be responsible for managing source documents for clinical trials.

Key Responsibilities

• Create and maintain accurate versions of source documents in compliance with GCP Guidelines and internal SOP
• Design and review source documents to ensure they capture all required data for clinical trials
• Coordinate updates and maintain version control of source documents while managing communication with site staff and internal departments

Required Qualifications

• Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline) or relevant experience
• Experience as a Clinical Research Coordinator with complex clinical trials preferred
• Proficiency in e-Source build and design, as well as creation of paper source templates
• Ability to interpret clinical trial protocols for accurate source document design
• Strong IT skills, particularly in Excel, and willingness to learn new computerized programs