CRIO Study Build & Configuration
• Build and configure CRIO studies based on approved protocols, schedules of events, eCRF guidelines, Lab Manual and sponsor requirements and documents
• Design visit structures, assessments, forms, and workflows to support accurate eSource data capture
• Configure conditional logic, required fields, visit windows, and protocol driven workflows
• Ensure builds support both regulatory expectations and real world clinical execution
eSource & Systems Readiness
• Ensure CRIO builds align with protocol, ICF language, and data collection requirements
• Configure user roles, permissions, and access controls within CRIO
• Support system readiness activities prior to Site Initiation Visits (SIVs) and activation
Quality Control & User Acceptance Testing (UAT)
• Perform build QC to verify protocol accuracy, visit flow, and data capture integrity
• Lead or support UAT activities with PMs, SSU, and clinical stakeholders
• Address build updates, revisions, or corrections identified during testing
• Maintain documentation of build validation and readiness
Change Management & Amendments
• Update CRIO builds in response to protocol amendments, internal team review/feedback and sponsor feedback
• Maintain version control and ensure changes are appropriately tested prior to release
• Communicate system changes clearly to internal stakeholders
Secondary Responsibilities (Support & Collaboration)
Cross Functional Collaboration
• Partner with Study Start Up / Regulatory to align system builds with IRB approved documents
• Collaborate with Project Managers to ensure workflows support operational execution
• Participate in cross functional build review meetings to reduce downstream rework
Training & Adoption Support
• Support internal team training on CRIO workflows and study specific builds
• Provide guidance to clinical staff and PMs on system usage and navigation
• Assist with troubleshooting system issues during early study execution
Process Improvement & Standardization
• Contribute to development of standard build templates and best practices
• Identify opportunities to improve build efficiency, consistency, and scalability
• Support documentation of CRIO build standards and SOPs