Classification Title:
MGR, Clinical Research
Job Description:
The Department of Medicine, Division of Cardiology is seeking a full time MGR, Clinical Research. This position will function as a fiscal administrator of the Cardiovascular Medicine Clinical Trials Unit (CMCTU) under the direction of the Director and Associate Director of the Clinical Trials Program. The position will work to facilitate the continuing development and fiscal support of clinical trials and research grants with the Division of Cardiovascular Medicine. The responsibilities will include all fiscal startup management and closeout of all clinical trials and grants for the CMCTU. This position is also responsible for the startup, management and closeout for Dr. Michael Bubb’s Clinical trials in the Division of Rheumatology. Lastly, this position will oversee the day to day management of fiscal processing (accounts payable/receivable and patient stipends) and supervision of fiscal staff processors for the CMCTU.
Essential Functions;
Development of Fiscal management plan and budgets for each industry sponsored clinical trials and NIH, AHA, and other grant applications with PI, Director/ Associate Director, Coordinator Manager and Regulatory manager of the CMCTU.
1. Utilize UFIRST, OCR and other on-line systems to complete CDA and trial packet submissions.
2. Review sponsor protocols and informed consent templates,
3. Participate in research budget review with the CMCTU Admin group and Director/Associate Director
4. Identify where the protocol will occur and what UF ancillary departments will be involved.
5. Determine if Medicare qualification of trial is needed so that routine care can be billed to 3rd party for investigational trials, send to RBO for Medicare approval
6. Send out COS to departments for budgeting new Grant and or Clinical trials (CRC, IDS, ancillary UF health Departments)
7. Determine if an agreement will be necessary for Shands to negotiate and sign with the sponsor for devices or other supplies. Notify Shands and facilitate negotiations if needed.
8. Submit OCR Intake
Finalizing Budget of industry sponsored and NIH, AHA, and other grant applications
1. Following federal and UF guidelines
2. Submit final budget to OCR along with protocol-specific billing plan and grid to document procedures / services to be billed to the study and those that are to be billed to 3rd party under federal guidelines.
3. Set up invoiceable and tracking logs
4. Complete budgets and review with Principal Investigators.
Contract finalization
Review new clinical trial contract templates for payment schedule to ensure that all costs are covered in the payment schedule as compared to final Budget. Following UF guidelines regarding payment contingency language. Coordinate with CMCTU Regulatory manager to ensure that informed consent agrees with billing assumptions and the contract.
Facilitate post-award billing compliance.
1. 180 day review and update the research fiscal unit’s procedures to insure research billing compliance.
2. Identifying and resolving procedural issues that cross between the CMCTU study coordinator group and the CMCTU fiscal group and that impact negatively on the achievement of billing compliance for the CMCTU
3. Establish a fiscal procedure for CMCTU coordinators to use in ordering procedures and services for each clinical trial. This includes provision of the billing plan for the trial, subject payment amounts and procedures, and partially completed research service order forms
4. Meet with coo CMCTU Coordinator Manager to review procedures and address any questions or concerns.
5. Work with CMCTU Coordinator Manager and CMCTU fiscal staff to ensure that participant tracking sheets reflect the billing plan.
6. Ensure that protocol amendments resulting in changes in the billing plan for a trial are captured in the fiscal procedure and the participant tracking sheet and are updated with OCR.
7. Perform on-going financial analyses of grant accounts and coordinate work for completion and submission of grant progress reports. Identify any issues that the PI needs to be aware of and facilitate resolution.
8. Perform lead role on effort certification for division. Allocate research effort for all division faculty and staff, work with Division Administrator to enter non-research allocations, and submit reports for certification. Respond to all inquiries on research effort. Follow-up on certifications to ensure that timely completion of effort reports occurs.
Responsible for research component of annual FY budgeting process. Calculate research funds available for faculty FY research effort.
1. Identify research staff payroll sources. Develop FY research funded payroll distributions and work with Division Administrator to establish budgeted distributions for all faculty and staff.
2. Work closely with Division Administrator to meet all budget deadlines and deliverables.
3. Discuss research effort projections with faculty when needed.
Serve as a resource to the division, department, college and university in the area of clinical trial pre and post-award management.
1. Serve on College of Medicine working groups to provide input into the overhaul of sponsored research management systems at the university level.
2. Attend meetings and provide input when university policies are discussed with respect to financial management of clinical trials, such as meetings with C&G, OCR, UF Health Shands, FCAP and other research representatives on the establishment and use of operating accounts.
3. Serve as test-case for the implementation of new university policies in the sponsored research area.
4. Serve as a resource and provide training to department and division staff when asked about clinical trial budgeting and fiscal management.
5. Interact with research unit managers, division, department and college staff, with DSP and Contracts & Grants staff, UF Health SHANDS and FCPA staff, and with sponsors and grant agency staff, on various aspects of research management and processes.
Manage fiscal unit staff. Oversee all financial aspects of clinical trials and overhead and miscellaneous donor accounts (approximately 100 accounts and $18 million).
1. Responsible for research personnel payroll distributions and retroactive corrections while adhering to all guidelines with respect to justification/documentation.
2. Prioritize work within unit.
3. Provide customized report monthly to the CMCTU leadership on all division research accounts, miscellaneous donor accounts, overhead return accounts, and operating accounts.
4. Provide data on financial viability of CMCTU with a focus on payroll costs and projections. Respond to inquiries.
Other
Monitor the processing of each new trial and coordinate concise reporting on a weekly basis. Evaluate existing procedures for new trial start-up, identify problems, propose procedural modifications and assist in their implementation. Coordinate with CMCTU Admin to facilitate to minimize delays in processing new trials. Communicate with PIs when issues arise.
Expected Salary:
$80,000 – $90,000 Annually
Minimum Requirements:
Master-s degree in appropriate area of specialization; or a bachelor-s degree in appropriate areas of specialization and two years of experience.
Preferred Qualifications:
N/A
Special Instructions to Applicants:
“In order to be considered, you must upload your resume.”
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:
No
Advertised: 31 Aug 2023 Eastern Daylight Time
Applications close: 25 Sep 2023 Eastern Daylight Time