As part of the strategic research initiative, Fast Forward Clinical Trials (FFCT) is engaging the entire UMHS in creating a new model to improve clinical care, value, and health outcomes by more efficiently managing a diverse portfolio of high-quality clinical trials. This new model entails an organizational structure of local service units, central infrastructure, and governance oversight. The Clinical Trials Support Units (CTSUs) are trans-departmental and thematically aligned based on a research focus. CTSUs are the local units that provide comprehensive pre- and post-award support to study teams, offering high-quality, efficient service in support of a mix of clinical trials. They provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty.
The Contract and Grant Specialist will handle pre- and post-award research administration activities for the Ambulatory & Chronic Disease CTSU, with majority of the current emphasis on post-award. This position will also assist with the development of CTSU-specific workflows. In addition, this position will financially advise CTSU leadership by analyzing and monitoring the CTSU’s clinical trials portfolios, cash flow, breakeven points, and recommending actions to maintain positive margins.
Handle pre- and post-award activities ensuring all Medical School, University and sponsor policies and guidelines are followed. Specific pre-award duties include Unfunded Agreement (UFA), Clinical Trial Routing Form (CTRF), and Proposal Approval Form (PAF) creation and routing, budget creation and negotiation, and billing calendar preparation. Specific post-award duties include account reconciliation, processing patient reimbursement, invoicing the sponsor, resolving clinical research billing errors, ensuring revenue collection, projecting revenue and cash flow, and handling A21 and Financial Status Reports. Assistance in completion of progress and final reports as applicable.
In partnership with the CTSU Administrator, assist in managing the units’ clinical trials financial portfolios. Specific duties may include collecting and maintaining data for metrics; analyzing, forecasting, and reporting (i.e. monthly, annually) on the CTSU’s comprehensive financial portfolios. This position will assist in the preparation and presentation of financial portfolio reports to key stakeholders including the CTSU Advisory Board, Medical Directors, Administrators, each clinical trial cluster, and Clinical Trials Subcommittee.
Build and foster relationships with other units, as well as sponsors. Serve as liaison for faculty with sponsor, and University central offices (i.e. Sponsored Programs and ORSP).
Assist in the development and implementation of a plan to bring already existing/ongoing trials into the CTSU. This would require close collaboration with departments, faculty, study teams, research administrators, and others to ensure a smooth transition and completeness of records.
Other duties and special projects as assigned.
Bachelor’s degree or equivalent experience with 2-5 years of experience specifically in finance, management, business, or a related field.
Experience with pre- and/or post-award research administration activities, preferably clinical trials.
Solid understanding of sponsored projects, particularly the aspects of clinical research finances and reporting requirements.
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative, and effective manner.
Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
Excellent computer skills including proficiency in finance related programs/tools such as Excel, M-Pathways, M-Reports, and the Data Warehouse.
Ability to manage multiple tasks simultaneously, to work well under time constraints, and meet deadlines, as well as prioritize and exercise good judgment.
Understanding of some basic medical terminology.
Demonstrated experience working with a variety of sponsors including industry, federal agencies, cooperative groups, foundations, and gifts.
Experience with the U-M systems including The Michigan Budget Enrollment Calendar Tool (MBECT) and the Human Subject Incentives Program (HSIP).
Experience in financial management for a small business.
Knowledge of Medical School and/or University policies and procedures.
Direct supervision is received from the CTSU Administrator. Significant collaboration with the key administrators in stakeholder departments and centers is expected.
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