Regulatory Affair Project Manager - Los Angeles, United States - UCLA Health

    UCLA Health
    UCLA Health Los Angeles, United States

    1 month ago

    Default job background
    Full time
    Description

    The Regulatory Affair Project Manager will oversee, manage and participate in startup research activities as part of the Translational Clinical Research Unit while under the direction of Financial Administrative Officer, Faculty Director, Medical Director, and Research Director (Senior Management) of the Jonsson Comprehensive Cancer Center Clinical Research Unit.

    In this role, you will be responsible for the oversight of regulatory coordination for clinical research studies.

    This includes responsibility for regulatory coordination of clinical research studies, preparation, submission and maintenance of regulatory files to fulfill research requirements.

    Coordinating and reporting on the efforts/timelines of fund management, clinical trials administrative office and coverage analysis. Work with Study Monitors to process, review and collect the appropriate regulatory documents in a timely manner. Must have the ability to work flexible hours and/or overtime to meet study deadlines and requirements.

    Work may be assigned by Senior Management, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner.


    Monthly Salary Range:
    $5, $10,116.

    67
    QualificationsRequired:

    • Minimum of five years clinical research experience, with in-depth knowledge of clinical oncology.
    • Working knowledge of good clinical practices for clinical research.
    • Working knowledge in patient electronic medical system.
    • Working knowledge in working with Velos or similar system.
    • 4 or more years of experience in regulatory processes in clinical research.
    • At least a year of experience with UCLA IRB and/or other IRB.
    • Working knowledge of clinical research management systems.
    • Clinical research experience, with in depth knowledge of clinical oncology as it pertains to clinical trials and studies.
    • Demonstrated knowledge of "good clinical practices" for clinical research as defined by the FDA.