• Clinical Research Associate

    Posting Date 3 weeks ago(7/27/2018 8:52 AM)
    Requisition ID
    2018-4960
    Job Location(s)
    West Lafayette IN United States
    Travel
    50-75%
    Position Type
    Full Time
    Company
    Cook Research Inc.
    Category
    Clinical
  • Overview

    The Clinical Research Associate at Cook Research Incorporated is responsible for supporting the daily activities of clinical studies to ensure they are being conducted, recorded, and reported in accordance with the study plan/protocol, Cook procedures, applicable regulations and signed investigator agreements in order to meet global clinical study objectives.

    Responsibilities

    • Remotely monitor studies by sending queries, processing responses and ensuring that the dataset remains complete and accurate

    • Identify and report to project management any issues which may need attention at a particular investigative site; support resolution as needed

    • Ensure that data are entered into the appropriate database and any issues identified are promptly resolved

    • Travel to investigative sites to perform site visits if necessary, which may include, training, assessment of adherence with the study plan/protocol and applicable regulations, and general support and training of the physician and his/her research staff

    • Generate detailed and timely site visit reports as needed following each visit

    • Assist in the development and/or peer review of study plans/protocols, data collection forms, patient summaries, submissions to regulatory authorities, and other study-related documentation as needed

    • Compile and distribute the investigator file and brochure

    • Track IRB/Ethics Committee approval and renewals; prepare and respond to IRB/Ethics Committee submissions or correspondence

    • Track and archive essential documentation, such as insurance, agreements, CVs, etc.

    • Assist in checking device accountability, as appropriate

    • Work closely with both process and project management to determine priorities and ensure that project objectives are met

    • Establish trusted relationships with physicians, their research staff, the project team and study sponsors through communication and a commitment to exceeding expectations

    • Communicate information and study requirements to investigators or site personnel on an ongoing basis

    Qualifications

    • Bachelor's degree, preferably in a life science, nursing, pharmacy related field, or similar experience within science, healthcare or quality

    • Knowledge of applicable international standards and other regulatory requirements that may impact clinical studies is preferred

    • Conscientious, influential person with an outstanding work ethic and strong personal discipline

    • Willingness and capability to handle multiple projects and responsibilities

    • Excellent organizational and problem-solving skills

    • Excellent written, listening, and verbal communication skills

    • Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues

    • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

     

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