Clinical Systems Designer (PST/EST/CST Timezone)

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.