Note: The job is a remote job and is open to candidates in USA. Cardiovascular Associates of America - CVAUSA is seeking a Clinical Research Systems & eSource Specialist who will act as the operational and technical expert for clinical research systems. The role involves supporting the implementation and optimization of various research technologies, providing training, and ensuring compliance with protocols and regulations.
Responsibilities
- Support daily use of REALTIME CTMS, eSource, and eRegulatory modules
- Assist users with system navigation, troubleshooting, and workflow questions
- Support implementation of new research technologies and sponsor systems
- Participate in system testing, validation, and workflow optimization activities
- Assist with user account management and access requests
- Develop and maintain protocol-specific eSource templates
- Translate study protocols into efficient electronic workflows
- Build visit-specific source documentation
- Configure forms, templates, workflows, and data collection tools
- Standardize eSource practices across research sites
- Support quality review and refinement of eSource templates
- Evaluate coordinator workflows and identify opportunities for improvement
- Support implementation of standardized processes across sites
- Assist with development of study calendars, visit schedules, and workflow tools
- Collaborate with research operations teams to improve efficiency and compliance
- Deliver training on REALTIME and research technology platforms
- Develop user guides, job aids, and training materials
- Support onboarding of new research staff
- Assist sites transitioning from paper source to eSource
- Provide ongoing coaching and support to research personnel
- Assist with sponsor portal and system onboarding
- Support integration of sponsor workflows into site operations
- Maintain awareness of sponsor technology requirements
- Assist research teams with system-related study start-up activities
- Ensure systems support protocol compliance and regulatory requirements
- Participate in quality improvement initiatives
- Support audit readiness and inspection preparedness
- Assist with development of standardized documentation practices
Skills
- Strong clinical research background
- Understanding of how studies are conducted at the site level
- Highly technical
- Enjoys learning new systems
- Ability to translate clinical research workflows into efficient electronic processes and eSource solutions
- Support daily use of REALTIME CTMS, eSource, and eRegulatory modules
- Assist users with system navigation, troubleshooting, and workflow questions
- Support implementation of new research technologies and sponsor systems
- Participate in system testing, validation, and workflow optimization activities
- Assist with user account management and access requests
- Develop and maintain protocol-specific eSource templates
- Translate study protocols into efficient electronic workflows
- Build visit-specific source documentation
- Configure forms, templates, workflows, and data collection tools
- Standardize eSource practices across research sites
- Support quality review and refinement of eSource templates
- Evaluate coordinator workflows and identify opportunities for improvement
- Support implementation of standardized processes across sites
- Assist with development of study calendars, visit schedules, and workflow tools
- Collaborate with research operations teams to improve efficiency and compliance
- Deliver training on REALTIME and research technology platforms
- Develop user guides, job aids, and training materials
- Support onboarding of new research staff
- Assist sites transitioning from paper source to eSource
- Provide ongoing coaching and support to research personnel
- Assist with sponsor portal and system onboarding
- Support integration of sponsor workflows into site operations
- Maintain awareness of sponsor technology requirements
- Assist research teams with system-related study start-up activities
- Ensure systems support protocol compliance and regulatory requirements
- Participate in quality improvement initiatives
- Support audit readiness and inspection preparedness
- Assist with development of standardized documentation practices
- 3+ years of clinical research experience
- Experience as a CRC, Lead CRC, Research Manager, Regulatory Coordinator, or CTMS Administrator
- Experience using CTMS, EDC, eSource, eRegulatory, or sponsor systems
- Experience creating source documents and visit worksheets
- Understanding of clinical trial workflows from feasibility through study close-out
- Experience training research personnel preferred
- REALTIME experience strongly preferred but not required
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