The CTMS Study and Support Analyst is a key member of a growing team of staff responsible for implementing and maintaining the single enterprise Clinical Trial Management System (CTMS) at the University of Minnesota. This role functions as the first level application support as well as develops study-specific data capture forms for the CTMS application, OnCore. This role is also responsible for monitoring and reporting on the quality of the OnCore data as well as supporting training events. This position requires superior human relation skills for key interactions with researchers, research staff, service providers, administrators, application and data owners.
Additional Information: The University of Minnesota is implementing a single enterprise Clinical
Trial Management System (CTMS). The solution supports a broad range of clinical trial research, from the University's Clinical and Translational Science Award (CTSA) funded clinical trials unit, cardiology, oncology, public health, pediatric medicine, epidemiological, and other University health-research programs.
40% Application Administration, Support and Analysis
- Provide tier 1 support for Enterprise OnCore issues and requests.
- Oversee administrative aspects of the application such as adding new choices to pick lists, new staff members and institutions. Manage the process for adding and removing user access as well as auditing user access. Keep administrative tracking documentation up to date.
- Develop, service, and maintain the Single Enterprise OnCore support/help-line. Track and resolve user issues, requests, and enhancement ideas.
- Coordinate with the CTMS vendor on system configuration and support questions
- Develop, modify, and test user roles, design access rights, configure Enterprise OnCore for use by clinical and functional groups.
20% Create study-specific electronic case report forms (eCRFs) for research data capture and analysis.
- Collaborate with research staff and Biostatisticians to develop, test, and approve eCRFs.
- Train research staff on appropriate eCRF usage for specific studies.
- Develop and maintain the forms library within CTMS. Develop standards for form templates.
- Troubleshoot data collection challenges and provide technical support for eCRFs.
- Develop and maintain processes/guidelines for creating, maintaining, and testing data capture forms within CTMS.
20% Quality Assurance and Compliance Monitoring
- Manage and maintain the quality assurance plan.
- Develop and implement data quality assurance techniques for data elements used Enterprise-wide. Track and monitor data quality and compliance to help inform areas requiring further training or process improvement.
- Deliver data quality trend reports to the OnCore team manager and area managers. Deliver detailed QA reports to study staff for resolution.
- Work with the CTMS Business Analyst to document reporting requirements for the development of automated QA and compliance reporting.
- Work with the CTMS Trainer and Customer Experience Coordinator to ensure QA trends are addressed though training and group refreshers.
10% Application Training
- Provide ongoing advanced instructional guidance and training for various levels of research personnel.
- Support training sessions and lead portions of training for new and existing OnCore users.
- Conduct CTMS training breakout sessions for specific areas of the CTMS for new CTMS users or current users.
- Develop training materials.
10% Other Duties as Assigned
- Other duties will include but will not be limited to: Provide expertise, input, and support for the ongoing OnCore implementation, lead OnCore demonstrations and Q & A sessions for groups within the research community, and attend team meetings.