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 projects in accordance with institution standards.
Must complete required IACUC training. Attend IACUC board meetings when projects are scheduled for review.
Other: Work with the PI and provide monthly report 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.
Supervision/Management: Support and provide guidance on administration of compliance, financial, personnel, and other aspects of Clinical Research. Responsible for coordinating activities administered by the research programs, the development and implementation of procedures for the Clinical Research program in Vascular Surgery. Supervise research support staff engaged in the carrying out of research and clinical protocol. Plans and directs clinical research activities for Vascular Surgery section.
Data Management: Responsible for subject enrollment and patient follow-up for all approved projects. Maintains/collects data for study patients accurately and completely. Reviews 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 in a timely manner. Responsible for collecting and compiling data for chart review studies.
Patient Care: 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 family as related to the study. Perform subject screening and consent for clinical protocols under direction of Principal Investigator. Monitors and observes patients under the direction of the PI as it relates to study procedures. Communicate daily with research patient 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 obtained by LAR.
Other Administrative:
Schedule procedures, especially those involving multi-disciplinary efforts. Communicate with nursing and/or OR staff regarding patient care per protocol. Assure strict compliance of study subjects with study protocol with regards to surgical procedures, imaging, labs, and clinic visits. Access medical records from HIS, EPIC, LCR and Data Support Services for results on diagnostic studies, labs, clinic notes, operative reports, etc. Review medical records for medications, vital signs, past medical history, past surgical history, etc. Attend surgery to record data on source documents, intra/post-operative randomization.
Collect follow-up data from the hospital charts, assessments, and clinic visits. Communicate with patient coordinators/office staff regarding follow-up appointments for study patients. Inform the PI of SAE’s and obtain signatures on IRB/sponsor SAE reports. Track Disbursements and payments of invoices.
Coordinate sponsor site visits with PI, research staff and required facility staff. Be available to sponsor representatives that visit site to view regulatory documents, research records and patient medical records. Provide sponsor representatives electronic medical record and research record access. Maintain research lab space. Schedule research lab equipment maintenance and maintain calibration records.
Order lab supplies and submit receipts to the p-card team. Train study personnel on proper lab safety protocols. Dispose of biohazardous waste (i.e. patient blood and urine samples processed in the research lab) according to EH&S policy. Prepare research lab space for Environmental Health & Safety inspections.
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