Source Document Specialist

Job Summary

A company is looking for a Source Document Specialist to create and manage source documents for clinical trials.

Key Responsibilities

• Create and maintain accurate versions of source documents in compliance with GCP Guidelines and internal SOP
• Review and update source documents based on protocol amendments and ensure they are equipped to record required data
• Manage communication with site staff and organize, file, and archive source documents for each clinical trial

Required Qualifications, Training, and Education

• Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline) or equivalent experience
• Experience as a Clinical Research Coordinator with diverse clinical trials preferred
• Proficiency in e-Source build and design, as well as creation and revision of paper source templates
• Ability to interpret clinical trial protocols to design accurate source documents
• Self-motivated and highly organized individual capable of working independently