Clinical Research Coord III - GI Surgery
Job ID:
Location:
Job Views:
Job Description:
Classification Title: |
Clinical Research Coordinator III - GI Surgery |
---|---|
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 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.
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: 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. |
Expected Salary: |
$52,500 - $65,000; commensurate with education and experience. |
Minimum Requirements: |
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. |
Preferred Qualifications: |
Experience as a Clinical Research Coordinator is required. Must be able to communicate with patients and family participating in Clinical Trials. |
Special Instructions to Applicants: |
To be considered, you must upload your cover letter and resume. The University of Florida is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Application must be submitted by 11:55 p.m. (ET) of the posting end date. |
Health Assessment Required: | Yes |