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 financial setup and budget negotiations.
As a member of the CTFS team, this position will support a new Clinical Translational Research Services Department (CTRS). The aim of the new CTRS is to facilitate rapid clinical trial-start up and implementation for multisite trials locally, regionally and nationally.
Clinical Trial Management System (CTMS) Specification Creation and Maintenance (45%) â— Conduct a thorough analysis of research protocols to determine the specific protocol-required procedures, tests and timing of each. This requires review of the high-level details of the schedule of events along with the specific information in the procedural/visit descriptions and may require communication with project managers. â— Create a schedule of events in the CTMS to reflect what is required by the protocol for accurate clinical trial data capture and financial tracking. â— Develop a study-specific Excel workbook and send to research staff to collect information as needed. â— Revise the CTMS calendar based on feedback from the study team or protocol amendments. â— Enter financials in CTMS system. Pre-Award duties (30%) Protocol/contract review/ budget development/support Senior Pre-award staff â— Work with research study staff (Investigators, Coordinators, Project Managers, etc.) to review the study protocol and develop the study budget, including the billing grid and per-patient costs (requires use of the OnCore (clinical trials management system). â— Obtain additional study related materials and contact sponsor for clarification as needed. â— Review study budget with research staff to ensure that all relevant study costs have been included. â— For industry-sponsored studies, review and negotiate contract payment terms and amounts with the sponsor. â— Ensure timely processing of all pre-award steps to avoid delays in starting trials. â— Compare protocol and contract documents for consistency. â— Act as a liaison with the Sponsored Project Administration (SPA) department and academic department finance/administration to facilitate communications, ensure document submissions, and resolve any contract issues. â— Update and maintain clinical trial contract and financial data in the OnCore system. â— Update and maintain sponsor metrics database. â— Maintain metrics for pre-award activities.
Post award duties (15%): Account initiation, project set-up, ongoing involvement during study conduct â— Work to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants. â— Renegotiate payments from sponsor and process contract and budget amendments as needed.
Other (10%): â— Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes, document procedures, etc. â— Other duties as assigned.
About the Department Program/Unit Description: The Clinical Trials Financial Services (CTFS) team supports clinical trials by providing staff skilled in understanding and negotiating contracts, as well as providing financial management and oversight for clinical trials.
From initial negotiations to eventual close-out, our dedicated team negotiates, analyzes, recommends and regularly reviews the financial components of a clinical trial. This enables the principal investigator and study team to respond to issues in a timely manner, often preventing cost overruns.
The pre-award budgeting and contract negotiation team â— Develops budgets to project trial costs. â— Negotiates agreements and financial plans for funding costs. â— Facilities contract approval.
(All required qualifications must be documented on application materials)
Required Qualifications: â— A bachelor’s degree in business administration, finance, accounting, or related field and two years of business experience that may include contract/grant budget development, sponsor negotiation or clinical trial administration OR a combination of 6 years of education and relevant experience. â— Demonstrated problem-solving abilities and analytical skills. â— Ability to build effective working relationships with the CTFS team, sponsors, external service providers and research teams. â— Advanced Excel skills/experience (ability to link data and create complex worksheets used for clinical trials pricing) â— Attention to detail. â— Excellent written and verbal communication skills. â— Strong reading comprehension skills in order to understand research protocol. â— Willingness to learn medical billing policies and procedures.
Preferred Qualifications: â— Experience with software used to manage clinical trials or experience with other technical software. â— Familiarity with relevant clinical procedures. â— Familiarity with clinical trials.
Internal Number: 330882
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.