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    Clinical Research Coordinator - Columbus, United States - Columbus Community Clinical Oncology Program

    Columbus Community Clinical Oncology Program
    Columbus Community Clinical Oncology Program Columbus, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Department:

    Cancer Control / Cancer Care Delivery Research

    Reports To:

    Executive Director

    Date Prepared:

    April, 29, 2024


    Position Summary:

    Responsible for all aspects of clinical compliance and data quality for assigned research bases within the Columbus CCOP organization. Performs quality assurance and quality improvement of data for assigned NCI and industry clinical trials. Maintains a thorough knowledge of assigned protocols and adheres to all research principles and guidelines for meeting timelines and data management requirements.


    Essential Duties & Responsibilities:

    Clinical/Regulatory Compliance:

    • Function as liaison and expert resource to internal and external staff for CC/CCDR protocols such as timepoints, steps, data submission, etc.
    • Assess, interpret, and communicate key elements of protocols to staff, nurses, and physicians to assure clinical compliance
    • Maintain and review tracking mechanisms for data submission, enrollment statistics, credits and create reports when needed
    • Review and assess data for adherence to eligibility and timepoint requirements for duration of study.
    • Review Deviation and SAE Reports to identify violations and facilitate corrective actions to ensure future compliance with study parameters
    • Submit required regulatory documentation for IRB review within required timeframes
    • Review and assess Expectation Reports and advise appropriate personnel of delinquencies related to the protocol
    • Confer with CCOP Principal Investigator and management to review feasibility of protocol participation

    Quality Assurance and Improvement:

    • Establish indicators and timelines to measure compliance with active group protocol standards/requirements and develop QA forms
    • Review appropriate clinical trial data (for assigned research bases) submitted to the CCOP for timeliness, completeness, and accuracy to ensure audit compliance
    • Make recommendations to management for improvement to QA processes and procedures for assigned protocols
    • Perform internal and external audits as needed to ensure compliance with study parameters

    General:

    • Maintain a high level of audit preparedness for all areas of responsibility
    • Maintain a working knowledge about personal computer and software, including Microsoft Office products (e.g. Excel, Word, PowerPoint)
    • Prepare and maintain detailed desktop processes and procedures for all areas of responsibility
    • Keep management informed of all problems, potential problems, or issues that could have significant consequences for the Columbus CCOP
    • Adhere to confidentiality policies including HIPAA compliance

    Other Responsibilities:

    • Perform routine duties independently, setting priorities and schedules with minimal management direction
    • Accept new duties and assignments with a positive attitude
    • Perform duties and assignments with a professional demeanor.
    • Promote and facilitate teamwork and productivity with Columbus CCOP staff, management, and Columbus CCOP members
    • Assist other team members when needed
    • Demonstrate commitment to the CCOP Mission

    Potential Exposures:

    Infectious Disease

    Electrical Equipment

    Blood Contact

    Mechanical Equipment

    Chemicals

    Burns

    Radiation Equipment

    Other: Lift/carry up to 25 pounds

    X


    Education and Experience:

    A bachelor's degree in a healthcare or health science field or nursing required; two years experience in clinical research or knowledge of clinical research required; data collection, data entry, and data reporting experience required; knowledge of medical terminology required; computer skills, experience (Microsoft) required.

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