CRIO & eSource Specialist II

Position Overview

The CRIO & eSource Tool Specialist is responsible for the end-to-end management of the CRIO platform, with a strong emphasis on eSource creation, template design, and system administration. This role ensures that study teams are equipped with accurate, compliant, and protocol-specific eSource documents to support efficient, high-quality clinical trial execution.

The Specialist will serve as the primary point-of-contact for CRIO tool usage across research sites, providing system configuration, troubleshooting, and training. Candidates with prior experience in clinical trials, interventional studies, and eSource systems are highly preferred.

Key Responsibilities:

System Administration

• Oversee day-to-day operations of the CRIO platform, including user account management, permissions, and access control.
• Configure workflows to ensure alignment with study protocols and site SOPs.
• Monitor system performance and escalate technical issues to CRIO vendor support as needed.

eSource Creation & Template Management

• Design, build, and validate eSource templates for clinical trial protocols.
• Ensure protocol-specific fields and required data points are captured accurately.
• Standardize and optimize reusable templates to enhance consistency across studies.
• Maintain version control and documentation for templates.

Compliance & Quality Assurance

• Ensure all eSource templates and tool usage adhere to GCP, ICH, FDA 21 CFR Part 11, and other applicable regulations.
• Conduct periodic audits of eSource workflows and documentation.
• Support regulatory inspections and sponsor audits related to eSource utilization.

User Support & Training

• Act as first-line support for CRCs, investigators, and site staff.
• Develop and deliver training sessions on CRIO system usage and best practices.
• Create and maintain quick-reference guides and SOPs to support user adoption.

Cross-functional Collaboration

• Partner with clinical operations and data management teams to ensure seamless data capture and integration.
• Collaborate with sponsors and CROs to confirm acceptance of eSource outputs.
• Collaborate with the Finance team to develop and maintain standardized templates that streamline billing and collections processes.
• Provide feedback to leadership on opportunities for workflow improvement and system enhancements.
• Foster strong cross-departmental relationships to align business, clinical, and financial priorities.
• Manage complex protocols and coordinate with multiple functions to ensure accurate and timely study execution.

Qualifications

• Bachelor's degree in Life Sciences, Clinical Research, or related field required.
• 5-7 years of experience in clinical research operations, data management, or a related discipline.
• Hands-on experience with eSource platforms (CRIO preferred; others such as Florence, RealTime, Veeva SiteVault acceptable).
• Strong knowledge of clinical trial processes, especially interventional studies.
• Familiarity with regulatory compliance requirements (ICH-GCP, FDA 21 CFR Part 11).
• Excellent organizational, problem-solving, and analytical skills.
• Strong written and verbal communication skills with the ability to support end-users effectively.