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.

Clinical Trial Management System (CTMS) Specification Creation and Maintenance (40%)
● 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.
● 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.
● Develop a study-specific Excel workbook and send to research staff to collect information as needed.
● Revise the CTMS calendar based on feedback from the study team or protocol amendments.
● Enter financials in CTMS system.

Pre-Award duties (35%)
Protocol/contract review/ budget development/support Senior Pre-award staff
● 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).
● Obtain additional study related materials and contact sponsor for clarification as needed.
● Review study budget with research staff to ensure that all relevant study costs have been included.
● For industry-sponsored studies, review and negotiate contract payment terms and amounts with the sponsor.
● Ensure timely processing of all pre-award steps to avoid delays in starting trials.
● Compare protocol and contract documents for consistency.
● 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.
● Update and maintain clinical trial contract and financial data in the OnCore system.
● Maintain metrics for pre-award activities.

Post award duties (15%):
Account initiation, project set-up, ongoing involvement during study conduct
● Work to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants.
● Renegotiate payments from sponsor and process contract and budget amendments as needed.

Other (10%):
● Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes, document procedures, etc.
● Other duties as assigned.