E-Source Designer

1 week ago

india, IN UniTriTeam Full time

Position Summary

We are seeking a detail-oriented E-Source Builder with hands-on experience designing and maintaining electronic source documents and e-regulatory binders in CRIO (required). The ideal candidate will also have experience performing the same role in Clinical Conductor and/or RealTime CTMS, including study build-out, procedure mapping, financial integration, and regulatory binder setup. This role is essential to ensuring studies are configured accurately and efficiently across systems, supporting both compliance and operational excellence.


Key Responsibilities

  • Study Build-Out
  • - Translate study protocols into compliant, user-friendly e-source templates in CRIO.
  • - Build study visit schedules, assessments, procedures, and workflows in CRIO, and ideally in Clinical Conductor and RealTime as well.
  • - Ensure builds meet sponsor/CRO requirements and site operational needs.
  • E-Regulatory Setup & Compliance
  • - Develop and maintain electronic regulatory binders in CRIO, with preference for experience doing the same in Clinical Conductor and RealTime.
  • - Ensure compliance with FDA, ICH-GCP, and 21 CFR Part 11 regulations.
  • - Standardize filing procedures and QC document uploads.
  • Financials & Budget Integration
  • - Map study procedures to financial tracking in CRIO, with the ability to replicate this process in Clinical Conductor and RealTime.
  • - Collaborate with finance teams to align billing with study requirements.
  • - Ensure contracted budgets are accurately linked to procedures and site invoicing.
  • Quality & Process Improvement
  • - Develop SOPs and best practices for e-source and e-regulatory build processes.
  • - Perform QC checks, gather coordinator/investigator feedback, and update builds accordingly.
  • - Maintain full documentation and version control for study builds.
  • Collaboration & Training
  • - Partner with Clinical, Regulatory, and Finance teams to deliver accurate builds.
  • - Provide training, support, and troubleshooting for CRIO and other CTMS builds.


Qualifications

  • Bachelor’s degree in Life Sciences, Clinical Research, or related field (or equivalent experience).
  • At least 1 year of direct experience building e-source and e-regulatory in CRIO (required).
  • Experience performing e-source and e-regulatory builds in Clinical Conductor and/or RealTime CTMS (strongly preferred).
  • Strong understanding of clinical trial protocols, regulatory compliance, and site operations.
  • Ability to map procedures to budgets/financials in CTMS platforms.
  • Strong attention to detail, documentation, and version control.
  • Excellent communication and collaboration skills.


Preferred Skills

  • Experience across multiple CTMS/EDC platforms (with e-source build responsibilities).
  • Process optimization and SOP development experience.
  • Knowledge of site-level finance, billing, and reconciliation workflows.


Key Success Metrics

  • Accuracy and compliance of e-source and e-regulatory builds.
  • Timely completion of study build-outs.
  • Reduction in errors, deviations, or billing mismatches.
  • Positive feedback from coordinators, investigators, and regulatory staff.


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