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BSD OCR- Clinical Trials- Financial Group

About the Department

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division (BSD) and UChicago Medicine.

The mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

Job Summary

The Assistant Director will provide direct management and oversight of the budget negotiations, and/or post-award financial management for clinical trials within the BSD. They will manage a team of Budget/Contract Managers (BCMs), Financial Managers (FMs), Amendment Managers (AMs), and/or Financial Coordinators (FCs) within the CTFG and will report to the Director or Associate Director of the CTFG within the OCR.

Responsibilities

Directly manages a team of individuals responsible for performing clinical trial pre-award or post-award activities across the BSD. This team builds and negotiates clinical trial budgets and contract terms, on behalf of faculty with industry, federal, and private funding agencies.

Provides leadership and oversight in the execution and negotiation of clinical trial budgets, master clinical trial rate cards and pricing agreements with industry sponsors and partners.

Serves as a local expert in clinical trial budgeting and compliance. Acts as a key resource for clinical trial budget management across the BSD.

Align SOPs with other key divisional groups to use as reference materials and to ensure consistent processes are followed across the CTFG and BSD.

Develop metrics to ensure proper staffing levels are maintained to meet key objectives and timelines.

Works closely with Operations and Regulatory teams across the BSD.

Works closely with URA to consistently meet NIH and NCI designated start-up timelines.

Provides input and analysis to help manage multi-investigator grants, multi-site IITs, and single-site IITs.

Builds and negotiates clinical trial budgets and contract terms industry, federal, and private funding agencies.

Advises BSD faculty and staff on matters related to clinical trial budgets and contracts in a clear and professional manner.

Reads and interprets clinical trial study documents including Protocol, Budget, Contract, Informed Consent, and Laboratory Manual.

Ensures document harmonization and compliance and facilitates timely execution of agreements.

Provide input into CTMS implementation and utilization.

Successfully interacts with other departments, core facilities, and administrative offices to ensure efficient operation at all levels.

Establishes professional relationships with pharmaceutical, CRO, and non-profit counterparts to facilitate amicable and timely negotiations.

Contributes to data analysis, using established and novel metrics, to advance Unit and Department efficiency and profitability.

Manages multiple concurrent projects, paying special attention to competing deadlines, complexity, and priority.

Seeks new avenues for funding and grant opportunities and ensures that notices of relevant opportunities are brought to faculty attention. Works with sponsors to draft proposal budgets in accordance with university needs, with a moderate level of guidance and direction.

Reviews all applications against university guidelines, in addition to drafting progress reports, non-competing applications, amendments, and budgeting. Responsible for all data entry and preparation of grant reports and trend analysis.

Attend in-person meetings, presentations, conferences as required on an occasional basis.

Supervises employees that provides specialized support for the research enterprise within a department or unit, including pre- and/ or post-award administration for all sponsored activity. Serves as liaison between PIs, University administrative offices, and external agencies.

Supervises employees directly including selection, training, performance appraisal and work allocation. Ensures service and communication to PIs, standardized information, best practices development, and that all faculty and research staff are aware of any new grant policies and changes.

Monitors industry trends and remains current with agency and regulatory changes. Plans for department/ unit compliance with University, Divisional and Department policies and procedures and implements corrective actions for issues identified.

Develops performance goals, allocates resources and asse