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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

    1 week ago

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    Description

    Job Description

    Job Description

    Department:

    Clinical Operations

    Reports To:

    Executive Director

    Date Prepared:

    April 29, 2024


    Position Summary:

    Responsible for all aspects of clinical compliance and data quality for cancer treatment protocols within assigned research bases. Maintains a thorough knowledge of assigned protocols and adheres to research principles and guidelines for meeting time lines and data management requirements. Ensures CCOP Drug Accountability while executing the daily operations on Investigational Drug handling.


    Essential Duties & Responsibilities:


    Clinical/Regulatory Compliance:

    • Function as a liaison and expert resource for assigned clinical trial protocols between CCOP staff, management, and research bases.
    • Assess, interpret, and communicate key elements of protocols to staff, nurses, and physicians to ensure clinical compliance
    • Maintain and review tracking mechanisms for data submission and enrollment statistics
    • Verify eligibility for potential patient participation
    • Enroll and register clinical trial participants with research bases as needed
    • Review and assess patient treatment data for adherence to dosing and toxicity requirements
    • Receive and submit clinical trial pathology specimens according to NSABP protocol
    • Ensure investigational drug accountability conforms with protocol specifications
    • Review Deviation and SAE reports to identify protocol violations and recommend corrective actions to ensure future compliance
    • Review and assess Expectation Reports and collaborate with research nurses to correct delinquent data submission
    • Participate with CCOP Principal Investigator, CCOP Administration, and fellow research coordinators in reviewing protocols for feasibility when required
    • Submit required regulatory documentation to IRB for review within required timeframes

    Drug Accountability:

    • Assist with all aspects of drug ordering, receiving, storage, and distribution of investigational drug or devices according to NCI and FDA regulations
    • Maintain drug accountability forms
    • Maintain security of the drug distribution area at all times
    • Ensure secure storage of investigational drug
    • Maintain records of drug room and refrigerator temperatures utilizing manual and/or electronic recordings

    Quality Assurance and Improvement:

    • Adherence to Good Clinical Practices addressing data accuracy and completeness
    • Review clinical trial data for timeliness, completeness and accuracy to ensure audit compliance
    • Provide recommendations for improvements to QA processes and procedures
    • Participate in internal audits as needed to ensure protocol compliance

    General:

    • Maintain a high level of audit readiness for all areas of responsibility
    • Maintain a working knowledge of personal computer and study specific 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 clinical trial issues that may impact the Columbus CCOP, clinical trial participants, or affiliates of the CCOP/NCORP
    • Participate in grant preparation as requested
    • Adhere to confidentiality policies including HIPAA compliance

    Other Miscellaneous 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

    X

    Blood Contact

    Mechanical Equipment

    X

    Chemicals

    X

    Burns

    Radiation Equipment

    Other: Lift/carry up to 20 pounds

    X


    Education and Experience:

    Bachelor's degree in nursing required; one year 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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