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.