eSource Architect

Adams Clinical

16d•$60,000 - $65,000

About The Position

Adams Clinical is seeking a detail-oriented and proactive eSource Architect to oversee the development, maintenance, and quality control of electronic source (eSource) documentation across our multi-site research network. This role plays a critical function in ensuring that source documentation is accurate, compliant, and operationally ready in alignment with ICH-GCP, FDA, and IRB requirements. The eSource Architect reports directly to the Associate Director of Quality Assurance and works closely with the Regulatory, Operations, and Finance teams to support both study start-up activities and the day-to-day management of source amendment requests. The successful candidate will balance efficiency and compliance, ensuring that eSource is finalized ahead of trial activation and that amendment requests are processed rapidly with precision. A central focus of this role is to optimize eSource design and workflows so that site clinical research staff can execute study protocols seamlessly, thereby reducing protocol deviations, improving protocol and regulatory compliance, and trial efficiency.

Requirements

Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar).
Demonstrated experience with source/eSource creation and/or electronic data capture platforms (e.g., ClinicalResearch.io, Medidata Rave, or similar) preferred.
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

Experience building eSource through Clinical Research.io (CRIO) is a plus.

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.