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    Clinical Research Coordinator III - Gainesville, United States - University of Florida

    University of Florida
    University of Florida Gainesville, United States

    3 weeks ago

    Default job background
    Description

    Classification Title:
    Clinical Research Coordinator III - Cardiovascular Surgery


    Job Description:


    Manage ongoing clinical research trials within the Division of Cardiovascular Surgery to ensure trial protocol compliance, subject safety, and fiscal compliance.

    Coordination of Protocol Subjects


    • Perform subject screening and consent for clinical protocols under direction of Principal Investigator and Clinical Research Manager.
    • Schedule subject diagnostic testing procedures and follow-up clinic appointments, attend clinic study visits, collect baseline and follow-up data from the medical record, document findings in appropriate source records and case report forms.
    • Serve as patient resource and educator for information regarding the study or clinical symptoms.
    • Communicate with nursing staff and OR staff about patient care according to protocols. Assist with operating room protocol requirements where appropriate.
    • Maintain knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct. Coordination and maintenance of HIPAA Compliance.
    • Report and follow up adverse events and serious adverse events, after discussion with Principal Investigator, to Sponsor and Investigational Review Board as required by protocol.
    • Travel to and attend Sponsor-hosted Investigator meetings to stay abreast of updates pertaining to the research trials.
    • Assist Clinical Research Manager with training of lower level research coordinators as needed.
    Facilitate Post-Award Billing Compliance


    • Develop participant tracking logs that reflect the billing plan.
    • Work with OR business team to ensure proper billing for investigational devices and procedures.


    3 Perform EPIC billing review multiple times each week to ensure proper billing compliance and timely release of Shands bills to 3rd party payers and/or patients.


    • Manage Human Subjects Payments for the trials to ensure that payments are in compliance with the approved IRB protocol, Informed Consent, and Institution policy.
    • Track all sponsor payments. Work with sponsors to reconcile any discrepancies between received payments and actual amounts owed.
    Maintain Regulatory Compliance per Good Clinical Practice Guidelines, the Federal Code of Regulations, and UF policy


    • Organize and maintain regulatory files for clinical studies performed. Obtain medical licenses, CVs, and training documentation for Division study personnel. Work with other UF departments to obtain necessary documentation for other UF investigators working with the Division of Cardiovascular Surgery.
    • Collect and maintain Shands lab certifications.
    • Design case report forms and source documents for clinical protocols where required.
    • Coordinate efforts of Investigational Pharmacist and maintain site records for Good Clinical Practice and sponsor guidelines.
    • Draft Informed Consent Forms. Ensure subject injury language within the ICF matches the FLA issued by the Office of Clinical Research. Obtain sponsor and IRB approval. Update as necessary when study changes are made. Inform patients regarding any study updates and re-consent as needed.
    • Prepare and submit IRB submissions throughout the course of each trial (e.g. initial and final reviews, study amendments, continuing reviews, pertinent sponsor correspondence, DSMB reports, etc.)
    • Report adverse events (AEs) and serious adverse events (SAEs) to the IRB, Sponsor, and/or FDA as required by the protocol and the Federal Regulations. Follow AEs and SAEs until resolution.
    • Schedule interim monitoring visits and assist monitors in verifying trial data integrity. Perform query resolution in the various electronic data capture systems.
    Laboratory


    • Complete all required training for working in a biological laboratory (e.g. Bloodborne Pathogens, Biomedical Waste Training, Chemical Hygiene Plan, Shipping and Transport of Biological Materials, etc.) and renew as needed to satisfy UF's Environmental Health & Safety requirements.
    • Prepare and ship central laboratory samples as per protocol requirements.
    • Keep lab clean and help Lab Manager prepare for annual lab inspections as needed.
    Maintains working knowledge of computing skills: Microsoft Word for Windows, PowerPoint, Access, and Excel. Facilitates efforts for ongoing database(s) within the Division.


    Expected Salary:
    Salary is competitive and 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.

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