Covance

  • Clin Res Assoc II

    Job Location(s) AR-Buenos Aires
    Job Number
    2018-24513
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Assures the implementation of project plans as assigned

    Site administration and site monitoring responsibility for clinical studies according to Covance SOPs, ICH guidelines and GCP

    Site management responsibility for clinical studies according to Covance SOP, ICH Guidelines and GCP

    Act in the role of as a local Project Coordinator

    Education/Qualifications

    University Degree ( life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology)

     In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered

    Thorough knowledge of ICH Guidelines and GCP including a  basic understanding of regulatory requirements

    Thorough knowledge of monitoring procedures

    Basic understanding of clinical trial process

     

    Experience

    Two years of clinical research monitoring experience ( including PSV, SIV, RMV and COVs)

    Ability to monitor study sites independently according to monitoring guidelines, SOPs, GCP and ICH Guidelines

    Have full understanding of the Serious Adverse Event reporting process, process production of reports, narratives and FU of SAEs

    Good planning, organization and problem solving abilities

    Ability to work with minimal supervision

    Good communication and interpersonal skills

    Good analytical and negotiation skills

    Computer competency

    Fluent in local language and English, both written and verbal

    Works efficiently and effectively in a matrix environment

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