The Data and Support Analyst is a key member of a team responsible for implementing and maintaining the enterprise Clinical Trial Management System (CTMS), known as OnCore, and other clinical trial research systems at the University of Minnesota. This role functions as support, data management, and training lead for CTMS use within the Minnesota Cancer Clinical Trial Network (MNCCTN). The Data and Support Analyst will also create study-specific data capture forms within an Electronic Data Capture (EDC) system. Beyond MNCCTN, the role serves as a support resource, leads data quality assurance activities, and represents the CTMS and MNCCTN teams as a subject matter experts on several projects. This position requires the ability to provide an exceptional level of service and superior human relation skills for key interactions with researchers, research staff, administrators, and research support staff.
The Minnesota Cancer Clinical Trials Network (MNCCTN) is a cancer clinical trials network with locations across Minnesota, funded by the Minnesota legislature as a part of the University of Minnesota's overall MnDRIVE Strategic Investment Request. Led by the Masonic Cancer Center, University of Minnesota, MNCCTN partner organizations aim to improve cancer outcomes for all Minnesotans through greater access to cancer clinical trials in prevention and treatment. Learn more about the MNCCTN here: http://mncancertrials.umn.edu/
The duties below are split 50% time focusing on MNCCTN work and 50% time all other areas.
Data and Study Management (35%) • Complex multi-site protocol set up and management for MNCCTN studies in OnCore, including the protocol shell, globally shared and site-specific documents, staff information, and IRB review documentation. • Backup the CTMS Study Administrator to provide standard OnCore protocol set up and management for other areas. • Development and management of the MNCCTN OnCore operational and administrative data capture requirements, in collaboration with the OnCore team and Masonic Cancer Center. • Electronic data capture and case report form development and maintenance for MNCCTN, and backup development for other areas. • Identify reporting/analytics opportunities. Extract data and reports from OnCore to meet study-specific needs. Work with Health Sciences Technology (HST) staff to develop complex reports.
Application Administration, Support, and Analysis (30%) • Provide OnCore support for MNCCTN affiliate coordinators, project managers, and end users from other areas. • Serve as the OnCore subject matter expert and provide routine support as needed for the MNCCTN team and other areas. Provide support via phone, email, in-person and webinar-based office hours. • Manage end-user access for MNCCTN and serve as a backup for other areas. Keep administrative tracking documentation up to date. Track and resolve user issues, requests, and enhancement ideas. • Provide testing of OnCore changes during upgrades, implementations, and during change management activities.
Training (15%) • Train Clinical Research Coordinators (CRCs) and other study staff in OnCore use • Develop and maintain relevant documentation and training materials, including general OnCore training and study-specific materials, in collaboration with the internal CTMS team, Masonic Cancer Center, MNCCTN team and other stakeholders. • Create and maintain education content, including online education (eLearning) modules. • Lead presentations, participate in cross-functional group and team meetings.
Quality Assurance and Process Improvement (10%) • Serve as the lead for performing routine data quality checks and discrepancy management. • Work with Health Sciences Technology staff to access additional data sources and to automate QA data visualizations and reports. • Evaluate and identify areas for OnCore quality improvement using a variety of tools and data from multiple data sources to decease duplication and maximize uniqueness of OnCore data, improve consistency and timeliness of required information. • Work with the CTMS team to standardize access roles considering shifting needs and evolving technical capabilities. • Provide input for OnCore standard procedures and guidelines. OnCore documentation review and improvement. • Serve as a Subject Matter Expert on a multi-site study workgroup, led by the Clinical Research Support Center (CRSC). • Work to integrate activities through CRSC, where applicable.
Other Duties (10%) • Serve as a subject matter expert for MNCCTN staff for the interactions between OnCore and a new electronic regulatory binder (eBinder) system. Work with the CTMS team to provision accounts for the eBinder system. • Serve as a subject matter expert during new implementations. Immediate projects include an interface between OnCore and the eBinder system, and implementation of an electronic data capture system (EDC) that interfaces with OnCore. • Conduct initial and routine validation of the EDC system to ensure regulatory compliance. • Attend team meetings. • Other duties as-assigned.
All required qualifications must be documented on application materials.
Required Qualifications: • BA/BS degree with a minimum of 4 years of experience in regulatory, health care, or clinical research setting; or an advanced degree with 2 years of experience in regulatory, health care, or clinical research setting, or a combination of education and work experience in regulatory, health care, or clinical research setting to total 8 years. • Ability and desire to provide exceptional customer service. • Demonstrated experience working independently using initiative and good judgment. • Experience working collaboratively with teams. • Exceptional written and verbal communication skills. • Experience entering data into web-based applications at a high level of quality and comfortable handling problems with electronic data entry. • Experience developing training materials, planning and delivering training. • Demonstrated problem-solving abilities and analytical skills. • Demonstrated experience working independently using initiative and good judgment and with teams. • Proficiency with Microsoft Office, including moderate or higher skills in Excel or similar application.
Preferred Qualifications: • Knowledge of study design criteria, randomization processes, clinical and biomedical terms used in research studies, and scientific and medical concepts and terminology. • Experience using or supporting a clinical trial management system, electronic health record system, electronic data capture system, or regulatory system. • Experience with analyzing data quality and implementing quality assurance controls. • Experience with data extraction, using SQL, R, or similar tools. • Experience following instructions for new processes and contributing to continued improvement of processes and workflows. • Knowledge of clinical trial management operations. • Experience with system implementations. • Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research.
Internal Number: 336158
About University of Minnesota, Twin Cities
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