University of Florida · 2 days ago
Manager, Clinical Research- Vascular Surgery
Gainesville, FL
Full-time
Onsite
Mid, Senior Level
$98K/yr - $105K/yr
2+ years expUniversity of Florida is seeking a Manager for Clinical Research in Vascular Surgery. The role involves overseeing clinical research activities, ensuring compliance with institutional and federal regulations, and managing budgets and contracts related to research projects.
Higher Education
Responsibilities
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
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
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
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
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
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
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
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
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
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
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
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
Qualification
Required
Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience
Preferred
5 or more years of experience as a Clinical Research Coordinator preferred
Hold a current Clinical Research Certification (SOCRA or ACRP Certification)
Prior experience working in Vascular Surgery Research
Company
University of Florida
University of Florida is a public land-grant research university in Gainesville, Florida.
10001+ employees
H1B Sponsorship
University of Florida has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (388)
2024 (307)
2023 (278)
2022 (282)
2021 (169)
2020 (162)
Funding
Current Stage
Late StageTotal Funding
$6.83MKey Investors
Align TechnologyUS Department of EnergyNFWF
2025-06-02Grant
2024-09-17Grant· $2M
2024-09-10Grant· $0.18M
Leadership Team
Sri Kalyanaraman
Co-founder, VR for the Social Good Initiative
Chris Cowen
Senior Vice President and Chief Financial Officer
Recent News
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2025-12-02
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