• Clinical Scientist

    Posting Date 1 month ago(10/9/2018 2:14 PM)
    Requisition ID
    2018-5421
    Job Location(s)
    West Lafayette IN United States
    Travel
    20-30%
    Position Type
    Full Time
    Company
    Cook Research Inc.
    Category
    Clinical
  • Overview

    The Clinical Scientist at Cook Research is responsible for providing senior leadership and scientific expertise. In addition, the Clinical Scientist will coordinate with cross-functional teams in the development of strategy and oversight for the clinical study/program.

    Responsibilities

    • Develop and maintain relationships with physician experts (such as National Principal Investigators, Steering Committee Members) to meet company objectives for the project

    • Coordinate the presentation of information to DSMB, in accordance with the DSMB Charter, including, but not limited to, data summaries and presentations, study notifications, patient summaries, and attendance at meetings when necessary

    • Provide technical and scientific support/guidance for a specific project or area of treatment/technology or disease

    • Work with cross functional teams (Engineering, Regulatory, Business Units, etc.) to evaluate new clinical projects and study strategy

    • Develop clinical study designs and facilitate the transition of the project to clinical project management team

    • Review and provide input to clinical study-related documents, plans and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Clinical Study Overview Presentation, Progress Report)

    • Provide support and review materials for Investigator Meetings and Site Initiation Meetings

    • Lead efforts for the analysis, interpretation, presentation and reporting of clinical and imaging data to relevant stakeholders (project teams, executive management, physicians); collaborate with the Clinical Project Manager

    • In studies with an imaging component: Coordinate plan for receipt and review of imaging and coordinate efforts in the selection, training and management of core laboratory for independent review of imaging, as applicable

    • Work with relevant stakeholders to develop and execute publication and presentation plan for the study

    • Review study data and milestones, and coordinate study strategy with relevant stakeholders

    • Maintain effective communication with cross functional teams and stakeholders

     

    Qualifications

    • Advanced degree in Life Sciences or Engineering required, PhD or MD preferred

    Preferred candidates will possess a working knowledge of the regulations governing clinical studies with human subjects, and have extensive prior experience in clinical study operations and management

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

    • Sufficiently assertive to deal with confrontational situations while recognizing the need to communicate in an effective and diplomatic manner

    • Ability to present a professional and personable demeanor in all interactions

    • Experience in writing study protocols and other technical documents

     

    Physical Requirements:

    • Willingness and ability to travel 25-50% of the time

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