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    Clinical Research Coordinator II - Orlando, United States - DLCFL

    DLCFL
    DLCFL Orlando, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    This position is responsible for performing highly diverse clinical and administrative responsibilities requiring a high level of knowledge and attention to detail. This position requires assimilating vast amounts of information and processing information promptly and orderly. Personnel who fill this role must have a working knowledge of ICH/GCP guidelines. Specific studies are assigned as appropriate, and the coordinator is accountable to the Principal Investigator, Medical Director, and Clinical Research Manager.

    Qualifications

    • 1+ years of previous experience required as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials
    • Computer skills - Microsoft Word, Excel, PowerPoint, CTMS, EMR
    • Previous experience in a role of complex administration or project coordination
    • Effective communication skills, including written, verbal, and presentation skills
    • Strong attention to detail and organizational, analytical, and problem-solving skills
    • Periodic local travel to other practice locations on an as-needed basis

    Supervisory Responsibilities

    This position may serve a role in supporting/ mentoring junior coordinators and research assistants

    Job Duties/Responsibilities

    • Ensure the rights, safety and welfare of all subjects at all times
    • Ensure that each subject goes through the informed consent process following GCP guidelines, and consents to participate, before any study-related procedures are performed
    • Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately
    • Work in a collaborative, effective manner with Site personnel to meet research objectives completely and accurately
    • Responsible for understanding all internal policies and procedures approved by the Principal Investigator/Medical Director
    • Discuss study protocols with patients and verify informed consent documentation
    • Review patient medical history against Inclusion/Exclusion Criteria of studies
    • Perform blood draws, process and shipping of blood/urine specimens per study protocol and IATA regulations
    • Schedule all patient research visits and procedures consistent with protocol requirements
    • Dispense study medication, collect vital signs, and perform ECGs
    • Assist with routine data verification and quality control, ensuring data integrity and consistency with the prescribed study protocol
    • Provide the Sponsor with accurate and complete documentation and information
    • Provide accurate and complete documents for IRB submission on a timely basis
    • Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements
    • Retain and/or forward copies of forms as required by the Sponsor
    • Inform Sponsor of prospective FDA audits immediately
    • Prepare for FDA or Sponsor audit by ensuring all documentation and case report forms are available and complete
    • Provide subject education on an ongoing basis throughout their participation in the study
    • Report all adverse events to the Investigator, Sponsor and IRB.
    • Complete Study Logs in an accurate and timely manner in the appropriate electronic data system
    • Utilize a team approach including the PI, Sub-Investigators, other Coordinators and Research Assistant
    • Assist in the training of new staff members
    • Other duties as assigned
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