Source Document Specialist

📋 Description

• • The Source Document Specialist ensures accurate, compliant, and efficient clinical trial documentation by translating complex study protocols into clear, structured source documents that support high-quality data collection and regulatory compliance.
• • Day-to-day responsibilities include preparing and developing source documents (eSource and paper) based on clinical trial protocols, reviewing and validating documents for completeness and accuracy, maintaining version control, managing communication with site staff and study teams, organizing and archiving documents, supporting process improvements, participating in cross-functional meetings, conducting internal audits, and developing standardized templates and checklists.
• • Care Access is a global organization dedicated to making the future of health better for all, operating hundreds of research locations, mobile clinics, and clinician networks worldwide to bring world-class research and health services directly to underserved communities through initiatives like Future of Medicine and Difference Makers.
• • In this role, the specialist will deepen expertise in clinical trial documentation, regulatory compliance (GCP, 21 CFR Part 11), and global collaboration while improving documentation workflows, ensuring data integrity, and contributing to the accessibility and quality of clinical research across Brazil and international sites.