Clinical Research Coordinator


Department:
SOM KC Neurosurgery Education and Research

—–

Research
Position Title:
Clinical Research Coordinator
Job Family Group:
Professional Staff
Job Description Summary:
Provide administrative and research support for clinical research projects by working with the Research Institute, other departments, and outside entities cooperating in research efforts. Manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Work with research teams for protocol management and to ensure compliance with protocols guidelines, institutional policies and procedures, as well to strict adherence to the Good Clinical Practice Guideline. Interact with participants in clinical research studies. Identify problems and/or inconsistencies and monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.
Job Description:
Job Duties Outlined:

Work closely with the Research Institute and Human Subjects Committee and having working knowledge of KUMC Research Committee, and KU Medical Center policies and procedures.

Prepare and maintain trial regulatory documentation including correspondence with sponsor, KUMC Human Subject Committee, Clinical Research Administration and subjects. Assist in the preparation and maintenance of clinical trial contract documents and study budget.
Ensure adequate study supplies are maintained. Responsible for tracking study expenditures and submitting reimbursement requests for study equipment, supplies and study participants.
Under direction of PI, recruit and educate patients for clinical trials and evaluate potential patient eligibility for clinical trials. Perform subject visit procedures such as sample collection, processing, handling, shipping as required by protocol.
Submit electronic case report form data as required by clinical trial. Recognize and report adverse events/serious adverse events to the FDA and sponsors. Prepare and maintain source documents and case report forms (CRF’s) for clinical trials.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager as required.
Work closely with and assist study investigators in the preparation of investigator-initiated

study proposals and budgets.
Attend continuing education, research and training seminars.
Performs other duties as may be assigned by supervisor.
 

Required Qualifications:

Associates degree plus two years of experience in a health-related field, or management. Experience may substitute for a degree on a year-to-year basis. Must have 2 or more years’ experience in clinical research. Excellent communication, writing, organizational, and presenting skills. Ability to interact with multidisciplinary teams including patients, families, physicians, and administrative staff.

Preferred Qualifications:

Demonstrated understanding of database, spreadsheet and word processing software. Certification by ACRP or SoCra as a clinical research coordinator.

Required Documents:

    • Resume/CV
    • Cover Letter

    Employee Type:
    Regular
    Time Type:
    Full time
    Rate Type:
    Salary
    Pay Range:
    $53,000.00 – $83,000.00

    Minimum

    $53,000.00

    Midpoint

    $68,000.00

    Maximum

    $83,000.00

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