Manager, Clinical Research- Vascular Surgery

Classification Title:

Manager, Clinical Research Vascular Surgery

Classification 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.

Job Description:

Administrative: Institutional Review Board: Must be knowledgeable in institution IRB and Western IRB policies, procedures and standards of conduct. Create, coordinate and/or develop research protocols, informed consents and introductory questionnaires for IRB submission. Attend IRB board meetings when projects are scheduled for review. Correspond with IRB chairman as a representative of the PI when required. Liaison with the IRB, both University of Florida (myIRB, IRB01) and the Western IRB to develop, edit, and format consent forms and introductory questionnaires, incorporate sponsor consent and revisions into appropriate IRB format, submit to the IRB in a timely manner. Maintain, on file, all protocols, consent forms, IRB approval letters, signed consents of patient. Assist the PI in providing research compliance and oversight related to all studies. Attend Investigator’s Meetings, as necessary. Must complete annual, bi-annual and tri-annual required training.

Budget and Contract: Work with the PI to coordinate and develop research project budgets, calculating personnel and facilities costs. Work closely with facility lab, Investigational Drug Pharmacy, Radiology, Vascular Lab and clinics to create fiscal research accounts. Forecasts expenditures for the entire project budget period of the project to ensure that the project is neither over spent nor inappropriately underspent. Negotiate budget and fees with the Sponsor. Manage fiscal research accounts and collaborate with the facility in order to ensure billing compliance. Responsible for monitoring and maintaining daily activities for all projects, including approving research related charges, payments to patients, payments to facilities and ensuring that expenditures comply with project guidelines. Work with CMS (see below) to ensure Medicare billing is appropriate. Create and submit project invoices to sponsoring agencies for patient related charges and per patient enrollment fees.

Research Administration and Compliance and UF Contracts: Must be knowledgeable in policies, procedures and standards-of-conduct that promote adherence to applicable laws, as well as to the requirements of the facility, institution, federal, state and private funding agencies. Must complete annual and bi annual institution billing and compliance training. Create project billing plan that shows who will be paying the costs of all items, services and activities required by the protocol. Submit project to the Office of Clinical Research and Contracts with all required forms related to project drug, device, treatment, billing plan, Medicare billing status and confirmation of services from facility. Work with the facility to create a study billing account number (R99). Correspond on a per patient basis with facility to ensure compliance in billing. Provide daily review in EPIC of potential research related charges. Maintain a tracking log with all per patient project related billable charges and work closely with Department fiscal managers to ensure appropriate billing and invoices received from facility for research related charges.

Centers for Medicare & Medicaid Services (CMS): Determine if project is Medicare Qualifying and if there is potential for Medicare reimbursement. Determine if project must be pre-identified as “V70.7”, “MQ0” or “MQ1” on billing grid so facility will know the correct coding for claims. Create and submit Medicare billable studies to CMS for approval after IRB approval and prior to patient enrollment. Provide and annual report to CMS outlining all project related Medicare billing accounts. Provide billing office (i.e. clinic or EPIC) with necessary information so correct coding is submitted on claims.

Project Close Out: Ensure that all research related charges are settled prior to study closure. Review all payments to ensure that they were made by the appropriate source, and that all services billed to research participants and their third-party payers were not paid with study funds. Provide project tracking log, study budget, R99 agreements, protocol, contracts and amendments and IRB documentation to CTC auditors.

ClinicalTrials.gov: Submit protocol registration and results information to ClinicalTrials.gov, a web-based data entry system that provides public access to a directory of federally and privately supported clinical trials that test the effects of drugs, biologics, devices and procedures on medical diseases and conditions per institution and government requirements.

IACUC: Must be knowledgeable in Institutional Animal Care Committee (IACUC) compliance processes. Responsible for submitting and maintaining animal