Dignity Health

  • Clinical Research Regulatory Specialist

    Job ID
    2018-61142
    Employment Type
    Full Time
    Department
    Dignity Health Research Institute Administration
    Hours / Pay Period
    80
    Facility
    St Josephs Hospital and Medical Center
    Shift
    Day
    Location
    PHOENIX
    State/Province
    AZ
    Standard Hours
    M-F 8:30am-5:00pm
    Work Schedule
    8 Hour
  • Overview

    Located in the heart of Phoenix, Ariz., St. Joseph's Hospital and Medical Center is a 586-bed, not-for-profit hospital that provides a wide range of health, social and support services with special advocacy for the poor and underserved. St. Joseph's is a nationally recognized center for quality tertiary care, medical education and research. It includes the internationally renowned Barrow Neurological Institute, the Muhammad Ali Parkinson Center, the Norton Thoracic Institute, a campus of Creighton University's Medical School and the first Level I Trauma Center in Arizona verified by the American College of Surgeons. U.S. News & World Report routinely ranks St. Joseph's among the best hospitals in the United States for neurology and neurosurgery. For more information please visit our website at https://www.dignityhealth.org/arizona/locations/stjosephs.

    Responsibilities

    Position Summary:
     
    The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. 
     
    Principal Duties and Accountabilities:
    • Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits.
    • Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required.
    • This position interacts with a variety of customers, both internal and external, requiring exceptional communication skills.
    • The ability to multi-task and remain organized in a high volume clinical trial setting is required.
       

    Qualifications

    Education and Experience: 
    • Associate degree or equivalent combination of education and experience
    • Minimum 3-5 years related experience.
    • Previous training in the area of regulatory submissions, research administration or other clinical trial experience.
    • Proficient to advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills.
    • Preferred: Professional certification in research; CCRP, CCRC, CIP, or RAC.
    • Preferred: 5 + years of experience and Bachelor's degree.

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