eSource Architect

Adams Clinical, Inc.; United States; Remote; USD 60,000 - 65,000; Full time

Benefits offered by this job

401(k) matching

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Job summary

Adams Clinical is seeking a detail-oriented eSource Architect to oversee the development, maintenance, and quality control of electronic source documentation across our multi-site network. This role ensures source docs are accurate, compliant, and trial-ready per ICH-GCP, FDA, and IRB requirements.

The position reports to the Associate Director of Quality Assurance and collaborates with Regulatory, Operations and Finance teams to support study start-up and day-to-day amendment management,

Qualifications

• Minimum 2 years of clinical research experience.
• Experience with eSource creation or electronic data capture platforms preferred.
• Strong knowledge of ICH-GCP, FDA regulations and IRB requirements.

Responsibilities

• Develop new source builds across all active and start-up studies, finalized before site activation.
• Review and implement protocol amendment updates promptly.
• Review and implement site-requested updates promptly.
• Drive standardization of the eSource build for data extraction and a cohesive platform.
• Oversee eSource verification with QA and finance prior to first patient/visit.
• Maintain audit-ready, compliant source documentation across sponsor, CRO, and regulatory expectations.

Skills

Clinical research

eSource

Documentation

Regulatory knowledge

Communication

Time management

Education

Bachelor's degree in science/health

Tools

ClinicalResearch.io

Medidata Rave

Job description

Join Us in Shaping the Future of Clinical Research

Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people makethedifference. Guided by our core values— Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration —we create an environment where meaningful work drives meaningful change.

At Adams Clinical,you’llfind:

• A culture of respect, transparency, and continuous improvement
• Opportunities for professional growth and learning
• A team dedicated to improving lives through innovation and integrity

Ifyou’repassionate about making an impactinclinical research and want to be part of a collaborative, mission-driven organization,we’dlove to have you on our team.

Job Role

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.

Key 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.

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

Pay:

$60-65k salary, commensurate with experience

• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave

Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate’s or employee’s qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status.

In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the requiredtime frame. Adams Clinicalparticipatesin E-Verify to confirm employment eligibility.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Adams Clinical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.