Source Document Specialist

Job Summary

Creating and maintaining source documents for clinical research studies, the remote Source Document Specialist will execute documentation in compliance with protocols and regulatory standards while providing guidance to site staff.

Key responsibilities

• Creates and updates source documents for research studies based on protocol amendments and site staff requests
• Maintains organized records of source documents and ensures compliance with regulatory standards and internal SOPs
• Provides training and support to site staff on best practices for source documentation

Required qualifications

• Bachelor's degree in a related field or relevant experience required
• 2+ years of experience in a source documentation role required
• Well-versed in the conduct of clinical trials
• Subject matter expert in ICH/GCP, regulatory requirements, and FDA and HIPAA policies