eSource Architect: Design Frictionless, Compliant Clinical Data

Adams Clinical, Inc.

United States

Remote

USD 60,000 - 65,000

Full time

3 days ago
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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

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,

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