In clinical and translational research, scientific discoveries are moved along a virtual path from the laboratory into real-word practice, leading to improved human health. This position will be a part of the Clinical Trials Financial Services Team (CTFS). The primary responsibility of this position is to initiate and oversee administrative start-up activities for clinical trials including creating clinical trial budgets and negotiating financial agreements with clinical trial sponsors. This position works closely with Principal Investigator’s (PI’s), administrators and study teams in the Clinical Trials Office of the Masonic Cancer Center and Pediatrics. A passion for supporting clinical trial study teams, finance experience, attention to detail and a strong client service ethic are important in this role. Contract negotiation experience is desirable. As a critical part of the Clinical Research Support Center (CRSC) at the University of Minnesota, our team is working with others across the University to start clinical trials more quickly and effectively. CTFS works on Business and Industry sponsored studies primarily, but also develops budgets for studies funded by non-profits, federal or state agencies or other funding sources.
Pre-Award Duties (60%): • Work with research study staff (Investigators, Coordinators, Project Managers, etc.) to understand the study protocol and develop clinical trial budgets including projected revenue and costs. • Serve as a primary relationship manager on behalf of CTFS for one or more U of MN departments. • Collaborate with Fairview Research Administration, University of Minnesota Physicians and other service providers to obtain cost estimates for budgeting. • Review draft budgets with research teams and administrators to ensure that all relevant study costs have been included. • Secure and document alternative funding sources for any anticipated financial deficits. • Review and negotiate contract payment terms and amounts with business and industry sponsors. • Act as a liaison with the U of MN Sponsored Project Administration (SPA) and academic departments to facilitate communications, ensure document submissions, and resolve any contract issues. • Oversee the administrative start-up and the financial set-up for clinical trials. • Prepare multi-year financial forecasts comparing projected income to anticipated costs (including inflation) over the life of the study. • Requires use of the clinical trial management system including OnCore. Post award duties (20%): • Account initiation, project set-up, and on-going involvement during study. • Ensure a smooth transition between pre-award and post-award project phases. Ensure that CTFS post award accountants and study staff understand all anticipated revenue and expenses. • Initiate and organize a study initiation/transfer meeting for study research staff and post-award accountant. Review relevant documents (NOGA, study budget, templates) and highlight contract performance and payment terms. • Assist post-award accountant as needed. Duties may include: review of non-standard charges for appropriateness; analysis of study income vs. expenses; assistance with collections or other business issues and/or renegotiate payments from sponsor and process contract and budget amendments as needed. Research unit operations (5%): • Become knowledgeable about clinical specialties for assigned research portfolio. Provide expertise on study financial issues, develop administrative standard operating procedures (SOPs), and assist with implementation of new systems and procedures. Other (15%): • Collaborate with post-award financial staff, CRSC team members and others to provide high-quality administrative support (as evidenced by satisfaction of research unit faculty and administration). • Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes, document procedures, etc. • Train/support other team members as needed. • Other duties as assigned.
Required Qualifications: (All required qualifications must be documented on application materials.) • A bachelor’s degree in business administration, finance, accounting, or related field and four years of finance or procurement experience; or a combination of education and relevant experience to total eight years. • Client-service orientation. • Attention to detail. • Ability to clearly communicate and discuss clinical trial budgets with research staff, sponsors and department administrators. • Ability to create positive working relationships with other CTFS team members and other internal and external partners.
Preferred Qualifications: • Experience with administration of clinical trial contracts and/or budgets at a pharmaceutical/medical device company or a research site. • Experience negotiating financial contracts or agreements. • Familiarity with clinical procedures. • Excellent communication skills, both verbal and written. • Ability to develop & implement a timeline / work plan, work efficiently and in a timely manner. • Exemplary organizational skills.
Internal Number: 340405
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.