The Division of Biostatistics seeks an experienced Operations Leader for the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), which is funded by the National Institutes of Health (NIH), conducts large randomized trials and epidemiological studies on HIV, influenza, Ebola, and COVID-19. INSIGHT includes several hundred clinical sites in 35 countries. In addition to regulatory, data management and biostatistical responsibilities for the clinical research performed, the U of M serves as the legal sponsor for many of these trials, which have studied treatments, therapeutics, and vaccines.
The primary goal of the INSIGHT research is to reduce morbidity and mortality associated with infectious diseases. The trials and studies conducted have substantial public health impact. The U of MN INSIGHT group is primarily responsible for ensuring that funding sources are secured for the network research, that the research is managed in accordance with the terms and conditions of applicable federal grants and contracts, that the research is conducted in a timely and safe way, that the data collected are of the highest quality, that all regulatory requirements are adhered to, and that study results are widely disseminated. This work requires close collaboration with multiple national and international partners, including four International Coordinating Centers (ICCs) in Copenhagen, London, Sydney, and Washington. INSIGHT staff at U of MN must have a broad range of expertise to carry out this large-scale international research.
This position provides comprehensive support for grant and contract proposals; financial management and reporting; administrative and regulatory activities at the network level; collaboration with INSIGHT national and international coordinating centers; and collaboration with federal agencies, other research networks, and pharma.
These activities take place in an environment that can quickly change, requiring the incumbent to be flexible, capable of adjusting priorities, problem-solve, and engage in multiple tasks contemporaneously. The position requires excellent oral and written communication skills.
1) Grant/Contract Funding Proposals (35%).
• Work closely with Principal Investigators on responses for Requests for Proposals, write financial and technical justifications, and ensure proposals are responsive to solicitations. • Prepare study budgets with CCBR assignments and effort allocations. • Determine subcontractor participation and develop budgets for drug distribution, specimen collection and management, IRB review, clinical trial insurance, and other direct costs. • Prepare study payment schedules that define fixed and variable costs for ICC study coordination and participant care. • Anticipate and prepare cost/no-cost study extensions. • Respond to grant/contract queries from funders and the UofMN Sponsored Projects Administration (SPA).
2) Grant/Contract Management (15%).
• Finalize study payment schedules for ICC subcontracts. • Prepare work scopes for all subcontracts. • Work with SPA on study account setup, negotiation of task orders with contractors, and issuance of subcontracts. • Work with Biostatistics accounting staff on submission of periodic tracking and reporting of study spending.
3) Study Specific Tasks (40%).
• Assemble call notes. • Secure clinical trial insurance for research sites in select countries. • Assist the Principal Investigator with negotiation and execution of research legal documents (e.g., clinical trial agreements, confidentiality agreements, data transfer agreements, Material Transfer Agreements, etc.). • Work with Biostatistics accounting staff to maintain accurate effort assignments. • Prepare information required for Professional Service Contracts (e.g., vendors, community representatives, medical monitors, etc.). • Work with statistical support to create build ICC payment reports and related financial algorithms. • Ensure issuance of quarterly ICC study payments. • Assist with study supply logistics.
4) Miscellaneous Tasks (10%).
• Establish vendor accounts. • Assist with drug distribution management. • Assist with website development. • Assist with personnel management.
The University of Minnesota offers a comprehensive benefits package including:
· Competitive wages, paid holidays, vacation and sick leave · Low cost medical, dental, and pharmacy plans · Health care and dependent daycare flexible spending accounts · Excellent retirement plans with employer match · Disability and employer paid life insurance · Wellbeing program with reduced insurance premiums · Tuition reimbursement opportunities covering 75%-100% of eligible tuition · Student loan forgiveness opportunity · Opportunities for growth and promotion · Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2020_tcd-fpa-75100-ben-0105-10_cs_final.pdf
Required Qualifications: BA/BS with at least 10 years of experience or advanced degree plus 8 years of experience.
Past experience with grant/contract administration, preparation of funding proposals, financial management, and clinical trial research.
Preferred Requirements: Masters’ degree
Internal Number: 337549
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.