The Application Support Analyst is a key member of a team responsible for implementing and maintaining applications to support clinical research at the University of Minnesota (UMN). The flagship application is the enterprise Clinical Trial Management System (CTMS) which is used across the UMN Health Sciences and M Health Fairview. Recently added applications include an electronic regulatory binder and an electronic data capture (EDC) application. This role functions as the first level application support for the CTMS application, OnCore. Additional duties include developing study-specific data capture forms in the EDC, provisioning user accounts in eBinders, helping with upgrades and feature additions, and providing 1:1 help during office hours through the Clinical Research Support Center (CRSC). This position requires superior human relation skills for key interactions with researchers, research staff, service providers, administrators, application and data owners. The Application Support Analyst reports to the CTMS Director, within the Clinical and Translational Science Institute’s Biomedical Informatics Program. The IT applications listed above support a broad range of clinical trial and health-related research, including cardiology, oncology, public health, pediatric medicine, epidemiological, and other health-research disciplines.
Primary Duties: User Account provisioning, Support, Application Administration, and Analysis – 70%
Manage the process for adding and removing user access as well as auditing user access. Develop, modify, and test user roles, design access rights, configure applications for use by clinical and functional groups.
Provide tier 1 support for issues and requests for multiple complex, mission-critical research applications: Enterprise OnCore CTMS and Advarra EDC. Collaborate with the CTSI Regulatory Specialist team to provide tier 1 support for Florence eBinders. Escalate more complex issues to teammates and product vendors.
Develop, service, and maintain the Single Enterprise OnCore/EDC support/help-line. Collaborate with the CTSI Regulatory Specialist team to maintain the eBinders support process. Track and resolve user issues, requests, and enhancement ideas.
Provide 1:1 personalized OnCore support through the Clinical and Research Support Center (CRSC) office hours.
Oversee administrative aspects of the applications, such as adding new choices to pick lists, and adding new staff members and institutions. Keep administrative tracking documentation up to date.
Coordinate with the application vendors on system configuration and support questions. Hold routine meetings with the OnCore vendor’s support team. Attend meetings with the eBinders vendor, as-needed.
Support new and ongoing training activities in collaboration with the lead OnCore trainer.
Advance projects, application testing, and communications – 20%
Serve as an expert resource for a variety of projects, such as application upgrades, change initiatives, and new feature implementations. These projects will be led by various groups across Health Sciences. Serve as the point-person between the lead groups and the CTMS Team.
Lead application demonstrations and Q&A sessions for groups within the research community.
Craft and send mass-communications out to application users upon request by other team members.
Create study-specific electronic data capture forms for research studies and other assigned duties – 10%
â‹â‹Collaborate with research staff and Biostatisticians to develop, test, and approve data forms.
Train research staff on appropriate EDC usage for specific studies.
Develop and maintain the forms library within EDC. Develop standards for form templates.
Troubleshoot data collection challenges and provide technical support for EDC forms.
Develop and maintain processes/guidelines for creating, maintaining, and testing data capture forms within EDC.
Acquire and maintain software vendor-provided application certification, attend team meetings, and other duties, as-assigned.
All required qualifications must be documented on application materials
BA/BS degree and two years of related work experience; or an equivalent combination of education and related experience to equal six years.
Experience using web-based, secure-server applications and comfortable handling problems with electronic data entry.
Ability to manage multiple tasks and work with shifting priorities, schedules, and changes in management objectives.
Demonstrated problem-solving abilities.
Excellent ability to build strong working relationships with teammates and application users.
Supportive of a diverse, equitable, and inclusive workplace.
Demonstrated experience working as part of a team and independently using initiative and good judgment.
Proficiency with Microsoft Office or the Google Application suite, including moderate to advanced skills in Excel or Google Sheets.
Working knowledge of clinical trial operational processes from start-up through study conduct.
Experience assessing scientific and biomedical research protocols.
Demonstrated knowledge of study design criteria, randomization processes, clinical and bio-specimen terms used in research studies, and scientific and medical concepts and terminology.
Experience working in or supporting a clinical trial billing compliance or clinical trial management system.
Experience with an electronic data capture application.
Experience with an electronic regulatory binder application.
Experience in an academic healthcare environment or clinical research setting.
Experience with system implementations or upgrades.
Experience developing data collection forms for research.
Knowledge of Federal and Institutional confidentiality and regulatory policies applicable to electronic databases containing protected health information and data collected specifically for research (i.e. HIPAA, HITECH, FDA Title 21 Part 11)
Internal Number: 340787
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.