This position will work with the Research Director and Accounting Supervisor and is responsible for overseeing all clinical trials in the Department of Medicine. The Department of Medicine has close to 200 active clinical trials involving 45 PIs and over $3 million in funding.
40% Serve as ETHOS/OnCore/M Health/Fairview/Budgeting and Billing Compliance Policy department liaison/expert. Work with CTSI, Fairview, SFR and SPA, and UMP to ensure compliance with U of M research billing policies.
• Provide administrative review of all clinical trial proposals. Review protocols and budgets to ensure compliance with University and Departmental clinical trial policies. Assist study coordinators with study entry in OnCore. Review and authorize (sign off on) all clinical trial PRFs in the department. • Review OnCore information to support timely billing and collection of accounts receivables. • Assist accountants with Fairview invoicing, SFR billing and A/R, sponsors, etc. as necessary.
25% Supervise and manage departmental clinical trial staff including study coordinators and regulatory specialists. Responsible for a study team of 2 Regulatory Specialists and 7 Study Coordinators. Manage current clinical trial workload and assign coordinators to new studies.
20% Provide project management leadership for Department of Medicine initiatives to improve and increase clinical research, working with the CTSI, Medical School Dean's office, Fairview, and Principal Investigators.
10% Training for faculty, study coordinators, accountants and other study personnel in all aspects of clinical trials to include PI-initiated studies, budgeting, IRB applications, sponsor negotiations, etc. • Lead and collaborate on the development of internal processes that help reduce the compliance, operational, and financial risk of clinic trials for the department. • Collaborate with CTSI leadership and staff on development of organizational best practices around clinical trial management.
5% Develop departmental overview reports for clinical trial activity to be shared with the Department Chair, Vice Chairs for Research, Dean’s Office, AHC/CTSI, Center Director and department leadership. • May represent the Department on committees, task forces, etc.
Required Qualifications: Bachelors degree in Finance, Business Administration or related field with at least 6 years of professional research administrative experience, or an advanced degree in related field with at least 4 years of professional research administrative experience. Experience as a study coordinator or managing clinical trials. Demonstrated ability establishing successful partnerships with organizational leaders, managers, and staff.
Preferred Qualifications: Experience with EFS accounting and reporting tools. Completed OnCore training. Demonstrated ability to manage and lead complex projects. Experience participating in and leading process improvement projects. Demonstrated ability meeting project deadlines.
Internal Number: 331795
About University of Minnesota, Twin Cities
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