E-Source Designer

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

Preferred Skills

Key Success Metrics