Responsibilities/Duties: The CETI Data Solutions Group supports PIs of investigator initiated cancer research. The Data Solutions Coordinator reports directly to Scientific Director- Cancer Research Translational Initiative (CRTI). 40% Protocol Specific DMP and Research Support Work with the PI and study team to complete data management plans for each assigned investigator initiated clinical trial through the Masonic Cancer Center. This will include, but is not be limited to: using the OnCore clinical trial management system for the creation of electronic Case Report Forms (eCRFs) to capture data needed to answer study endpoints, reviewing subject calendars, and creating user manuals and assisting with clinical staff training. Develop protocol-specific Data Management Plans (DMPs) and data consultation reports, set up data review meetings, assist with interim and final data analytics, maintaining and updating the CRF template library, as well as setting up and attending protocol related meetings and work on REDCap projects. Develop and generate reports for MCC researchers as needed to ensure data requirements are being met according to approved Data Management Plans. Train staff on study specific protocol (eCRF) usage as needed, so that they can adequately meet the daily clinical trials related operational needs for the Clinical Trials Office team. Work with staff in prioritizing and ensuring clinical trials have all minimal requirements complete prior to activation, which includes communication and coordination with CTO managers, Research Nurses, Project Managers, Clinical Research Associates, investigators, statisticians, IT, and other clients. 30% - Perform ClinicalTrials.gov/ CTRP registration and reporting duties, work on Via oncology, SIP flow charts and other projects as assigned. 25% - Admin lead for sample inventory databases such as Freezerworks. Onboard new teams to freezerwork, oversee super-users across teams. Serve as a point of contact between Freezerworks and users of Masonic Cancer Center. 5% - Participate in cross functional teams to designing, modifying, or implementing new data collection tools, reports, dashboards, and resources. Assist in the development of training materials including new employee orientation training material to assist in protocol adherence and data quality (i.e. individual CRF manuals).
This position requires physical presence on campus 5 days a week. This position cannot provide visa sponsorship.
All required qualifications must be documented on application materials.
Required Qualifications: • BA/BS in Biological Sciences, Health Science, Computer Science, Informatics/ Public Health, Biostatistics; or related education and work experience in the area of business to equal 4 years in an area closely related to this position • Knowledge in clinical research • Excellent task and deadline management and communication skills • Ability to multi-task, work independently and in team with appropriate accountability • Strong organizational skills • Extensive computer experience in Microsoft Office
Preferred Qualifications: • Bachelor’s degree in Biological Science • Knowledge of GCP, medical and/or clinical trial terminology • Experience in protocol review, case report form development • Experience in OnCore, REDCap • Experience with data collection, analysis and reporting
Internal Number: 334510
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