Research Support - Laboratory/Non-Laboratory, Staff/Administrative
I. Clinical Trial Data Management (50%)
Manages a portfolio of clinical trials for the entire lifespan including but not limited to data base set up and creation, eCRF form creation and training, amendments and updates, data set extraction, abstract assistance, Data Management Plans (DMPs) etc.
Formulate and define the scope and objectives of complex, local trial data management plans by working with clinical staff and PIs/Sponsors
Document the data collection, analysis and reporting requirements for all local investigator initiated clinical trials and Sponsor trials
Affiliate Data Management and Training
Clinical Trial Management System (OnCore) Database Management
IND product data
Work with CTMS, Enterprise and CTO team members through the transition process of moving from eCRFs to EDC and follow up on issues until resolved satisfactorily
Assist with interim and final data analytics
Data extraction and compilation for quality checks
Data quality control to ensure accurate and efficient data management
Work on REDCap projects
Trial registration and results reporting to Clinical Trials.gov
Register and manage clinical trial data to CTRP
Collaborate with CISS on developing dashboards
Provide training and technical expertise to less experienced staff
II. DBUC Manager (30%)
Manage the MCC Data and Bio-specimen Use Committee (DBUC) and Operations.
Implement immediate process for integrated regulatory oversight of data and sample release to meet urgent need
Work with CISS/BIPC IT team and TTL to develop sustainable IT tools and process for regulatory oversight of requests for and release of integrated data/samples (linking DBUC scientific review and IRB review to release of samples from TTL or data from BMT Db/CISS/AHC-IE/BPIC). Serve as Business Analyst for this project to ensure that it 1) serves PI/researcher needs, 2) merges seamlessly with exiting UMN IT processes, 3) is in compliance with all relevant regulations and 4) is streamlined and efficient between UMN research service providers.
Develop the review processes (using new or existing tools) for review committees
Gather and document system requirements via 1-on-1 interviews, group discussions and surveys and generate the Software Requirement specification.
Perform system analysis of current toolset to identify if it meets the current requirements
Review Use Case (UC) from SME’s and determine if current technical toolset can be used to process and satisfy the UC, if not generate Software Requirement to build new toolset .
Review Test Plans with the CISS team to ensure created toolset will meet all acceptance criteria, and perform Quality Assurance testing as predetermined. In addition generate User Acceptance Testing (UAT) scenarios, and generate user and/or training manuals.
Maintains a close collaboration with SMEs across departments and organizational units, examine current operations and procedures and identify inefficiencies, bottlenecks and opportunities for standardization.
Develop and implement process to translate researcher requests into specific sample requests (for TTL) or data set requests (CISS/ICS)
Engage with researchers and software users to understand the business process that the software will enable and how the software should operate to improve efficiencies in that process and to add value
Serve as research liaison/navigator to MCC PIs to identify existing data/samples/genomics/biostats/bioinformatics support and/or collaborators for proposed projects.
Be a liaison to help the development team to understand the clinical research terms with a focus on cancer and move the Center towards using system standards. Map existing process to system functionality and perform a gap analysis. Being a liaison, this will be a technical pivotal role in ensuring IT and Business teams' understanding of requirements and mitigating any gaps and improvements.
Develop and implement tools to track Data and Biospecimen use metrics (with ROI such as #papers, #grants, #PIs served, etc).
Establish best possible business model to account for costs and future support for biospecimen collection and data sharing, with potential for billable services and revenue to offset costs
Ensure regulatory compliance and safety of multiple biospecimen banks including Immune-reconstitution Banks, Heme Malignancy Tissue Bank, Thoracic Translational Working Group Lung Cancer and Pulmonary Nodule Biorepository, Tumor Immune Monitoring Bank, Rare Disease Monitoring Bank and the growing Solid Tumor Bank
Work with the IRB, investigators and other involved parties to ensure regulatory compliance, in particular to facilitate effective and prospective patient consent for research use of stored samples.
Maintain regulatory compliance and manage biospecimen tracking among different bio-specimen banks (as stated above)
Serve as Business Analyst to develop and implement plans to transition existing MCC sample collections into this infrastructure
Develop QA plans (including reports) for biospecimen tracking and other data quality
III. Develop new processes and opportunities for growth to Data Solutions Group (DSG) and Cancer Research Translational Initiative (CRTI) (20%)
Work with CRTI leadership to identify and implement new opportunities for growth and expand workscopes for DSG and CRTI.
Track CRTI’s return on investments.
Perform monthly check on billables, invoices and report discrepancies to CRTI leadership.
Collaborate with cross functional teams to design, modify, or implant new data collection tools, reports, dashboards and resources.
Develop new processes, SOPs, training materials, templates, etc.
Work with CRTI leadership to conduct and facilitate presentations to sponsors and departments regarding DSG and CRTI services.
Other business analyst duties as assigned.
*Please note that this position cannot provide VISA sponsorship*
*This position requries a physical presence on campus five (5) days a week*
BA/BS degree required
2 years of work experience in the areas of business or systems process analysis with related degree or 4 years’ experience with non-related degree.
2 years of experience in process development, clinical research (protocol, data management, biospecimen management), and IT management of clinical research and biospecimen data.
2 years of work experience in the areas of system process analysis or translational research with a track record showing progressive levels of responsibility.
2 years of experience in process development, clinical research (protocol, data management, biospecimen management), and designing database for the management of clinical research and biospecimen data.
Ability to implement immediate solution for data and biospecimen request and release process in compliance with all local and federal regulations.
Ability to create effective partnership with leadership to execute and expand new processes.
Ability to manage projects and deadlines, manage people, develop training materials, SOPs and apply reason to business problems. Good judgment and the ability to express thoughts clearly and simply.
5 years of work experience in the areas of system process analysis or translational research with a track record showing progressive levels of responsibility.
3-5 years of experience in process development, clinical research (protocol, data management, biospecimen management), and designing database for the management of clinical research and biospecimen data.
Knowledge on OnCore, IRB, clinical trial process, REDCap, CT.gov and CTRP highly preferred
Track record of managing projects and deadlines
Interpersonal skills in creating effective partnerships with leadership
Business Analyst Certification
Experience developing training materials
Internal Number: 333667
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.