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Senior Source Creation

GI ALLIANCE • Austin, TX, US • published 2026-10-23 08:05:32.277627

Description

The Senior Source Creation Specialist ensures the accuracy and quality of research data by supporting quality control activities. The role is responsible for designing, developing, and maintaining study\-specific source documents to ensure accuracy, regulatory compliance, and alignment with study protocols. The Senior Source Creation Specialist also provides oversight, training, and guidance to junior Source Creation Specialists, including review of their work. This role is critical in supporting data integrity and inspection readiness. **JOB RELATIONSHIPS:** * Reports directly to the Director of Strategy and Operations and indirectly to Regional Research Managers and the Finance Manager. * Collaborates with finance, sponsors, site staff, quality, and regional site managers. * Bachelor’s degree in life sciences, healthcare, or related field. * 2–4 years of experience in clinical research, including source document creation. * Strong knowledge of GCP, FDA, and ICH requirements. * Excellent attention to detail and document management skills. * Complex specialty therapeutic area trial experience preferred. Ex: Urology, Neurology, Endocrinology, etc. * Ability to collaborate across mul...

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