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    Clinical Research Lab Tech - Los Angeles, CA, United States - CEDARS-SINAI

    CEDARS-SINAI
    CEDARS-SINAI Los Angeles, CA, United States

    2 weeks ago

    Cedars-Sinai background
    Description

    The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care.

    Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research.

    From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.

    Work alongside physician-scientists and researchers who are making life-saving medical and scientific breakthroughs. Our team of scientists develop some of the most advanced clinical trials in the world.

    As a Clinical Research Coordinator III, you will work independently providing study coordination including screening of potential research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.

    This position is responsible for the oversight of all studies with the group and the assignment of studies to clinical research personnel within the group, and supervision of research staff.

    The incumbent plans and coordinates strategies for growing research participant enrollment, improving efficiency, training of personnel, and identifying new research opportunities.

    The CRC III member ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

    Manages the clinical research portfolio and daily operations of studies for the investigator or disease group.

    In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; Maintains accurate source documents related to all research procedures.

    Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
    Schedules and participates in monitoring and auditing activities.

    Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at research staff meetings.

    Notifies direct supervisor about concerns regarding data quality and study conduct.

    Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters following local and federal guidelines.

    May involve other regulatory duties, budgeting duties, and assisting with research participant billing and reconciliation.
    Participates in required training and education programs.
    Works with Training and Education Coordinator to ensure all staff is properly trained and certified.
    Offers strategies to improve clinical research efficiency.
    Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans.
    Supervises other clinical research staff in day to day operations. Provides input in the performance review of the staff.
    Works on both industry sponsor initiated and investigator initiated clinical trials.
    Provides training to junior level coordinators.
    Invoices sponsors and pays clinical trial invoices.
    Prepares and manages clinical trial budgets.
    Supervises other research staff.
    Bachelor's degree, preferred.
    5 years of clinical research experience, required.
    Able to read papers and online documents.
    Able to operate standard office equipment

    Working Title :
    Clinical Research Coord III -Cheng Lab, Heart Institute

    Business Entity :
    Cedars-Sinai Medical Center
    Academic / Research

    Overtime Status :

    EXEMPT

    Primary Shift :
    Day
    Shift Duration : 8 hour
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