eSource Architect

Job Summary

Detail-oriented and proactive, the full-time eSource Architect will oversee the development, maintenance, and quality control of electronic source documentation across a multi-site research network, ensuring compliance with ICH-GCP, FDA, and IRB requirements while optimizing eSource design and workflows.

Key Responsibilities:

• Develop new source builds for active and start-up studies, ensuring readiness for site activation
• Review and implement protocol amendment updates and site-requested changes promptly to minimize operational delays
• Drive standardization of eSource builds and maintain audit-ready documentation aligned with regulatory expectations

Required Qualifications:

• Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar)
• Demonstrated experience with source/eSource creation and electronic data capture platforms preferred
• Strong knowledge of ICH-GCP, FDA regulations, and IRB requirements
• Bachelor's degree in a scientific, health-related, or administrative field (or equivalent work experience)
• Exceptional organizational skills with the ability to manage competing priorities across multiple protocols and sites