E-source designer

3 days ago

Malappuram, 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 Real Time 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 Real Time 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 Real Time. - 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 Real Time. - 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 Real Time 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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