Clinical Project Coordinator - eSource Specialist in Remote at Hawthorne Health

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