Endologix, Inc

  • Sr. Clinical Research Associate

    Job ID
    2018-1967
    Location
    US-CA-Irvine
    Category
    Clinical
  • Overview

    The Senior Clinical Research Associate will directly supervise all study management activities for the Company’s global clinical efforts. This is a team focused role working directly with other clinical and regulatory professionals; including working with CROs (Contract Research Organizations) involved in the Company’s clinical efforts, and integrating those efforts with other departments within the Company. Regularly interacts with regulatory agencies, physicians and other scientists involved in clinical research, and regularly participates as a key resource in the Company’s product development and commercialization efforts.

    Responsibilities

    • Project coordination, planning and logistics, including budget and timelines
    • Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout the trial
    • Responsible for the safety and proper conduct throughout the trial
    • Verifying that the investigator follows the approved protocol and all GCP (Good Clinical Practice) procedures
    • Verifying that source data/documents and other trial records are accurate, complete, and maintained
    • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs (Case Report Forms).
    • Communicating deviations from the protocol, SOPs (Standard Operating Procedures), GCP, and the applicable regulatory requirements to the investigator
    • Assist and/or manage activities and interactions with CROs and/or vendors.
    • Maintains all relevant documentation and communications as part of study files.
    • Coordinates clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required.
    • Adhere and assist with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides).
    • Review study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with the preparation and review of clinical study reports.
    • Perform other duties as assigned by supervisor.

    • Ability to travel up to 30%, based on project needs.

    Qualifications

    • Strong Multitasking and Project Management Skills - ability to coordinate or manage multiple projects across multiple centers.
    • Detail Oriented - unparalleled attention to detail and organization
    • Strong communication skills - communicates effectively in both written and interpersonal formats with all levels of the organization.
    • Consulting Skills – ability to work and partner effectively with others within the company and outside of the company.
    • Professional Conduct & Demeanor – projects a professional and polished demeanor in all situations.
    • Excellent Problem Solving Skills – ability to understand issues and communicate effectively with clients and team.

    Education:

    • Bachelor’s degree in a clinical, scientific, or related field required.
    • Advanced degree (Masters, PhD or MD) preferred.

    Experience:

    • A minimum of 4+ years of CRA experience in the Medical Device Industry. (Masters may substitute for one year of experience, PhD or MD may substitute for two years of experience).
    • Experience in Cardiovascular, Vascular, and/or Class-III Devices is highly preferred.
    • Experience as a Study Lead and/or Study Manager is highly preferred.
    • Experience with electronic data capture (EDC) systems is preferred.
    • Strong working knowledge of medical/scientific terminology and knowledge of FDA (Food & Drug Administration) regulations and GCP guidelines is required.
    • Advanced skills in Microsoft Office Suite and standard computer programs required.

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