Clinical Project Coordinator - eSource Specialist
United States
Full-time
Remote
2 months ago
About the role
We are seeking an eSource, CRIO build design specialist to support us with updating and building out multiple CRIO builds.
This is a 1099 opportunity.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. To view our privacy policy and terms of use, please use the links below. Privacy Policy: https://hawthornehealth.com/privacy-policy/ Terms of Use: https://hawthornehealth.com/terms-of-use/
CRIO Study Build & Configuration
eSource & Systems Readiness
Quality Control & User Acceptance Testing (UAT)
Change Management & Amendments
Secondary Responsibilities (Support & Collaboration)
Cross Functional Collaboration
Training & Adoption Support
Process Improvement & Standardization
This is a 1099 opportunity.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. To view our privacy policy and terms of use, please use the links below. Privacy Policy: https://hawthornehealth.com/privacy-policy/ Terms of Use: https://hawthornehealth.com/terms-of-use/
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