Clinical Trials Financial Services - Clinical Translational Science Institute
In clinical and translational research, scientific discoveries move along a virtual path from the laboratory into real-world practice, leading to improved human health. This position, in the Clinical Trials Financial Services Team (CTFS), has the responsibility 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 Cardiology and Pediatrics and other medical departments.
As a critical part of the Clinical Research Support Center (CRSC) at the University of Minnesota, our team is working to start clinical trials more quickly and effectively. The CTFS focuses on Business and Industry Clinical Trials but also develops budgets for studies funded by non-profits, federal or state agencies or other funding sources.
Roles and Responsibilities:
Pre-Award Duties (70%):
Work with research study staff (Investigators, Coordinators, and Project Managers) to understand the study protocol, develop clinical trial budgets and negotiate financial contracts.
Serve as a primary relationship manager on behalf of CTFS for one or more U of MN departments. Provide regular updates to departments on study status.
Develop and enhance relationships with internal clients, internal stakeholders, CROs and sponsors.
Collaborate with Fairview Research Administration, University of Minnesota Physicians and other service providers to obtain cost estimates for budgeting.
Secure and document alternative funding sources for any anticipated financial deficits.
Oversee the administrative start-up and the financial set-up for clinical trials and 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.
Prepare multi-year financial forecasts comparing projected income to anticipated costs (including inflation) over the life of the study.
Use of the clinical trial management system to create a unique schedule of events for each study.
Post award duties (10%):
Initiate and organize a study initiation transfer meeting including study research staff and the post-award accountant. Review relevant documents (NOGA, study budget, templates) and highlight contract performance and payment terms.
Assist the post-award accountant as needed. Duties may include a review of non-standard charges for appropriateness and an analysis of study income vs. expenses.
Renegotiate sponsor budgets as required and process budget amendments.
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 the implementation of new systems and processes.
Provide high-quality service as evidenced by satisfaction surveys.
Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes and document procedures.
Train/support other team members as needed.
Maintain metrics and update internal systems in a timely and accurate manner.
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
All required qualifications must be documented on application materials.
A bachelor’s degree in business administration or health care and a minimum of four years of work experience or a combination of related education and work experience to equal eight years.
Demonstrated commitment to quality, attention to detail and providing the highest quality services to internal and external customers.
Excellent planning, organization and time management skills. Able to manage multiple projects and priorities while accomplishing work efficiently and accurately.
Clear written and verbal communication skills with high proficiency in spelling, grammar, tone, and syntax.
Expertise in MS Word and Excel.
Understanding of clinical trial operations and budgeting from the trial start-up to close.
Experience with the administration of clinical trial contracts and budgets at a pharmaceutical/medical device company, CRO or a research site.
Superior negotiation skills.
Familiarity with clinical procedures.
Analytical skills, able to turn data into insights and drive recommended actions.
Internal Number: 330334
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.