eSource Architect

Summary

Adams Clinical is a clinical trial site network committed to accelerating the development of life-changing medicines through high-quality, safe, and diverse clinical research. The eSource Architect oversees the development, maintenance, verification, and quality control of electronic source documentation across multiple studies and sites, ensuring compliance with ICH-GCP, FDA, IRB, sponsor, and CRO requirements.

Responsibilities

• Develop new source builds across all active and start-up studies within the site network, finalized in advance of site activation to ensure enrollment readiness
• Review and implement protocol amendment updates promptly, minimizing operational delays while safeguarding regulatory and protocol compliance
• Review and implement site-requested updates promptly
• Drive standardization of the eSource build for data extraction, optimizing eSource systems to establish a cohesive platform that enables CRCs to execute protocol-required procedures consistently and accurately
• Drive the eSource verification process with the quality and finance teams prior to first patient, first visit across trials
• Maintain audit-ready, compliant source documentation aligned with sponsor, CRO, and regulatory expectations

Skills

• Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar)
• Strong knowledge of ICH-GCP, FDA regulations, and IRB requirements along with familiarity with sponsor/CRO expectations for regulatory documentation and source data verification
• 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
• Proven ability to meet strict timelines while maintaining accuracy and compliance in a fast-paced, deadline-driven environment
• Strong written and verbal communication skills; ability to collaborate across multidisciplinary teams
• Demonstrated experience with source/eSource creation and/or electronic data capture platforms (e.g., ClinicalResearch.io, Medidata Rave, or similar) preferred
• Experience building eSource through Clinical Research.io (CRIO) is a plus

Qualifications

Must Haves

• Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar)
• Strong knowledge of ICH-GCP, FDA regulations, and IRB requirements along with familiarity with sponsor/CRO expectations for regulatory documentation and source data verification
• 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
• Proven ability to meet strict timelines while maintaining accuracy and compliance in a fast-paced, deadline-driven environment
• Strong written and verbal communication skills; ability to collaborate across multidisciplinary teams

Nice to Haves

• Demonstrated experience with source/eSource creation and/or electronic data capture platforms (e.g., ClinicalResearch.io, Medidata Rave, or similar) preferred
• Experience building eSource through Clinical Research.io (CRIO) is a plus

Benefits

• 401(k) matching
• Medical, Dental, & Vision insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance