Job description
** Job Description: Clinical Systems 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 **
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Study Build-Out
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Translate study protocols into compliant, user-friendly e-source templates in CRIO.
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Build study visit schedules, assessments, procedures, and workflows in CRIO, and ideally in Clinical Conductor and RealTime as well.
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Ensure builds meet sponsor/CRO requirements and site operational needs.
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E-Regulatory Setup & Compliance
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Develop and maintain electronic regulatory binders in CRIO, with preference for experience doing the same in Clinical Conductor and RealTime.
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Ensure compliance with FDA, ICH-GCP, and 21 CFR Part 11 regulations.
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Standardize filing procedures and QC document uploads.
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Financials & Budget Integration
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Map study procedures to financial tracking in CRIO, with the ability to replicate this process in Clinical Conductor and RealTime.
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Collaborate with finance teams to align billing with study requirements.
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Ensure contracted budgets are accurately linked to procedures and site invoicing.
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Quality & Process Improvement
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Develop SOPs and best practices for e-source and e-regulatory build processes.
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Perform QC checks, gather coordinator/investigator feedback, and update builds accordingly.
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Maintain full documentation and version control for study builds.
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Collaboration & Training
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Partner with Clinical, Regulatory, and Finance teams to deliver accurate builds.
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Provide training, support, and troubleshooting for CRIO and other CTMS builds.
** Qualifications **
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Bachelor’s degree in Life Sciences, Clinical Research, or related field (or equivalent experience).
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At least 1 year of direct experience building e-source and e-regulatory in CRIO (required).
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Experience performing e-source and e-regulatory builds in Clinical Conductor and/or RealTime CTMS (strongly preferred).
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Strong understanding of clinical trial protocols, regulatory compliance, and site operations.
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Ability to map procedures to budgets/financials in CTMS platforms.
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Strong attention to detail, documentation, and version control.
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Excellent communication and collaboration skills.
** Preferred Skills **
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Experience across multiple CTMS/EDC platforms (with e-source build responsibilities).
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Process optimization and SOP development experience.
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Knowledge of site-level finance, billing, and reconciliation workflows.
** Key Success Metrics **
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Accuracy and compliance of e-source and e-regulatory builds.
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Timely completion of study build-outs .
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Reduction in errors, deviations, or billing mismatches.
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Positive feedback from coordinators, investigators, and regulatory staff.