Research Support - Laboratory/Non-Laboratory, Staff/Administrative
The CTMS Study Administrator is a key member of a team responsible for the administration of the enterprise Clinical Trial Management System (CTMS) at the University of Minnesota. This role is valued as an application expert, who will gather and analyze data from researchers and research teams and add the data to the mission-critical CTMS application, OnCore. Study entry requires interaction with multiple systems, research team members, and staff from various research support functions. This role is also responsible for working with the enterprise OnCore Administration team to provide OnCore administration, support, ancillary reviews, and office hour coverage. The Study Entry Administrator also serves as one of multiple bridges for research staff to the many research services offered through the Clinical Research Support Center (CRSC) of the Clinical and Translational Science Institute (CTSI). This position requires the ability to provide an exceptional level of service for key interactions with researchers, research staff, administrators, and research support staff.
CTMS Application Data Management – 40% • Analyze current study status and information from multiple data sources, and use expert knowledge of a complex research database to accurately enter initial research study information into OnCore. Correct and timely entry is required to adhere to various regulations and advance downstream research and compliance processes. • Work with study teams to confirm the accuracy of the data. • Validate study details in the OnCore application to ensure appropriate IT security setup for access to individual research studies. • Ensure that the CTMS software application is set up correctly to meet the individual needs for incoming research studies. • Consult with researchers to determine their study’s data and IT application needs. Advise researchers on which IT applications are available for their use in clinical research. • Coordinate with other application administrators and service providers to provide a holistic approach in providing IT solutions and services. • Connect study teams to various Clinical Research Support Center (CRSC) services. • Keep the CTMS study-level data up to date and accurate by comparing against other data sources. Continually update the OnCore database through study activation, in collaboration with the research team. • Capture and record aggregate study participant data for a sub-set of research studies.
CTMS Application Process Facilitation – 20% • Continually monitor study progress and prompt individuals and teams to advance the CTMS application-related study startup workflows, including but not limited to: scientific review entry, protocol calendar creation, calendar review, service provider pricing request, sponsor contract entry, budget sign-off, IRB approval entry, billing account setup, and final administrative review and entrees needed in the CTMS for study activation. • Analyze the various nuances within the study data to ensure accurate updates into the OnCore database throughout the study start-up process. Verify that technical application triggers occur to facilitate communications between groups. • Initialize the process to activate application training and access for new study team users. • Support end-users through hand-offs to other OnCore administrators as the researchers transition to directly manage the research participant data upon study activation.
Application Administration and Support – 20% • Provide tier 1 support for Enterprise CTMS issues and requests. Collaborate with the support lead and colleagues to ensure high quality support. • Track and resolve user issues, requests, and enhancement ideas. • Conduct administrative activities within CTMS, such as adding new choices to pick lists, new staff members and institutions. Add and removing user access. • Coordinate with the Enterprise CTMS Administration team and product vendor on system configuration and support questions.
Office Hour Coverage and Ancillary Reviews – 10% • Provide CTMS office-hour support and training at pre-determined times, based on a rotation with other staff, at the CRSC. • Conduct the CTMS ancillary review service, which is intended to help research principal investigators understand their CTMS study entry requirements based on the specific details of each study.
CTMS Process Improvement and Other Duties – 10% • Lead efforts to continuously improve the CTMS application study entry service workflow. Coordinate with team members to gather stakeholder feedback and make iterative process changes to improve efficiency and quality. • Other duties will include but will not be limited to: Provide expertise, input, and support for CTMS change management activities, test updates and system changes, special projects, and attending routine team meetings.
All required qualifications must be documented on application materials.
Required Qualifications: â— Bachelor's Degree or an equivalent combination of education and work experience to equal four years. â— Ability and desire to provide exceptional customer service. â— Experience entering data into web-based applications. â— Demonstrated problem-solving abilities. â— Demonstrated experience working independently using initiative and good judgment.
Preferred Qualifications: â— 1 or more years working in one of the following areas: health care, clinical research, or academic environment â— Knowledge of study design criteria, randomization processes, clinical and biomedical terms used in research studies, and scientific and medical concepts and terminology. â— Experience using a clinical trial management system, electronic health record system, or regulatory system. â— Proficiency with Microsoft Office, including moderate or higher skills in Excel or similar application. â— Experience assessing scientific and biomedical research protocols. â— Experience following instructions for new processes and contributing to continued improvement of processes and workflows. â— Knowledge of clinical trial management operations. â— Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research.
Internal Number: 341926
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.