• Clinical Research Coord I - Dept. of Surgery

    University of Florida (Gainesville, FL)


    Clinical Research Coord I - Dept. of Surgery

     

    Work type: Staff Full-Time

     

    Categories: Grant or Research Administration

     

    Department: 29770100 - MD-Transplant Center - Admin

    Classification Title:

    Clinical Research Coordinator I

    Classification Minimum Requirements:

    Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.

    Job Description:

    Coordination of Protocol Subjects & Data Collection:

    + Performs subject screening and consent for clinical protocols under direction of Principal Investigator.

    + Serves as patient resource and educator for information regarding the study or clinical symptoms.

    + Prepares and ships central laboratory samples as per protocol requirements.

    + Collects baseline and follow-up data from the medical record.

    + Documents findings in appropriate source records and case report forms.

    + Schedules and attends clinic appointments for patients as required by protocol.

    + Communicates with nursing staff and OR Staff about patient care according to protocols.

    + Assists with operating room protocol requirements where appropriate.

    + Records patient symptoms and adverse events in conjunction with care providers.

    + Reports and follows up adverse events and serious adverse events, after discussion with Principal

     

    Investigator, to sponsor and Investigational Review Board as required by protocol

     

    Coordination of Protocol Compliance

     

    + Maintains knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulation regarding clinical trial conduct.

    + Coordinates and maintains HIPAA compliance for assigned studies.

    + Communicates with interdisciplinary health team in care of patients involved in research studies to ensure regulatory compliance.

    + Interacts with local laboratories and diagnostic study centers to ensure clinical protocol requirements are complete for studies.

    + Coordinates efforts of Investigational Pharmacist and maintains site records for Good Clinical Practice and sponsor guidelines.

    Research Support

    + Assists medical and scientific partners to design protocol methodologies for basic science, preclinical studies, and clinical protocols.

    + Helps with protocol development and protocol endpoints to ensure statistical and clinical relevance of studies.

    + Assesses clinical needs by performing literature review and discussion with faculty advisors within Division.

    + Prepares and submits filings of protocols to Investigational Review Board and Animal Care Committees as needed.

    + Designs Case Report Forms and Source Documents for clinical protocols where required.

    + Assists with grant development projects as needed for preclinical studies within Division.

    + Assists with manuscript preparation and abstract submission for principal investigators.

    + Submits protocols to the RAC and IRB offices to assure compliance under the direction of the senior study coordinator.

    + Organizes and maintains regulatory files for clinical studies performed within Division.

    + Interacts with institutional Investigational Review Board under direction of Principal Investigator for clinical research protocols.

     

    Tracks the type of study services performed to ensure that they are compensated appropriately

     

    + Performs billing review for study subjects

    + Dispense human subjects' payment to study participants

     

    Other duties as assigned. 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:

    $43,000 - $52,000

    Required Qualifications:

    Associate’s degree or an allied health professional degree in an appropriate area and one year of

     

    relevant experience; or an equivalent combination of education and experience.

    Preferred:

    Excellent communication skills; must be able to communicate with patients and family participating in clinical trials.

     

    Experience as research coordinator preferred.

     

    Experience with patient data and/or databases.

     

    Proficient time management skills and ability to successfully manage multiple studies.

    Special Instructions to Applicants:

    In order to be considered, you must upload your cover letter and resume.

     

    Application must be submitted by 11:55 p.m. (ET) of the posting end date.

     

    This requisition has been reposted. Previous applicants are still under consideration and need not apply.

     

    Health Assessment Required:Yes

     

    Advertised: 15 Jul 2025 Eastern Daylight Time

     

    Applications close: 30 Jul 2025 Eastern Daylight Time