eSource Architect

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, and IRB requirements. The role also supports study start-up, protocol amendments, workflow optimization, and collaboration with Regulatory, Operations, Quality, and Finance teams.

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

Preferred

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

Source creation

eSource creation

Electronic data capture

ClinicalResearch.io

Medidata Rave

CRIO eSource building

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

Company

US clinical research sites for psychiatric and neurological trials

Watertown, Massachusetts, USA

https://www.adamsclinical.com/

Founded in 2011

201-500 employees

Qualifications

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

Minimum of 2 years of clinical research experience (e.g., Clinical Research Coordinator, Regulatory Coordinator, or similar).

Required skills

Clinical Research, eSource Creation, ClinicalResearch.io (CRIO), Medidata Rave, ICH-GCP, FDA Regulations, IRB Requirements, Source Data Verification, Regulatory Documentation

Preferred skills

Written and verbal communication

Experience

2+ years