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
- 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.
