E-Source Designer

3 weeks ago

India 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.

  • E-Source Designer

    3 weeks ago

    India 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,...

  • E-Source Designer

    3 weeks ago

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    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,...

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