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 consent, and introductory questionnaires for IRB submission. Attend IRB board meetings when projects are scheduled for review. Correspond with the IRB chairman as a representative of the PI when required. Liaison with the IRB, both the 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 and submit to the IRB in a timely manner. Maintain, on file, all protocols, consent forms, IRB approval letters, and signed consent of the 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, Cardiovascular 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 overspent nor inappropriately underspent. Negotiate budget and fees with the Sponsor. Manage fiscal research accounts and collaborate with the facility 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 a project billing plan that shows who will be paying the costs of all items, services, and activities required by the protocol. Submit the project to the Office of Clinical Research and Contracts with all required forms related to the project drug, device, treatment, billing plan, Medicare billing status, and confirmation of services from the facility. Work with the facility to create a study billing account number (R99). Correspond on a per-patient basis with the 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 the facility for research-related charges.
Centers for Medicare & Medicaid Services (CMS): Determine if the project is Medicare Qualifying and if there is potential for Medicare reimbursement. Determine if the project must be pre-identified as “V70.7”, “MQ0” or “MQ1” on the billing grid so the 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 an annual report to CMS outlining all project-related Medicare billing accounts. Provide the 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.
Other: Work with the PI and provide monthly reports and annual reviews or other agency-required reports (as needed.) such as CMS, Department of Defense, and private agencies. Keep the PI apprised of the fiscal status of their projects.
Data Management:
Responsible for subject enrollment and patient follow-up for all approved projects. Maintains/collects data for study patients accurately and completely. Review with PI any concerns regarding enrollment. Maintains multiple electronic databases based on individual projects. Submits monthly patient screening and prescreening information to multiple sources. Provide de-identified source documents to project sponsors for remote monitoring. Responsible for completing sponsor-requested data clarification and query forms promptly. Responsible for collecting and compiling data for chart review studies.
Direct Patient Engagement:
Correspond with referring physicians regarding Inclusion/Exclusion criteria of research candidates. Reinforce patient and family education as related to their study responsibilities. Provide education to patients and families as related to the study. Perform subject screening and consent for clinical protocols under the direction of the Principal Investigator. Monitors and observes patients under the direction of the PI as it relates to study procedures. Communicate daily with research patients or family regarding research status, participation, and plan or any questions they may have. Monitor daily patient’s ability to consent for self if Informed Consent is obtained by LAR.
Continuing Education: Attend national conferences, and drug-sponsored meetings regarding IND and new academic and pharma projects.
Other duties as assigned.