Covance

  • Clinical Research Associate II

    Job Location(s) AR-Buenos Aires
    Job Number
    2018-20319
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liase with vendors; and other duties, as assigned.

    General On-siteMonitoring Responsibilities

    Travel, including air travel, may be required and is an essential function of the job

    Prepare accurate and timely trip reports

    Undertake feasibility work when requested

    Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor

    Negotiate study budgets with potential investigators and assist Covance legal department with staetements of agreements as assigned

    Complete SAE reporting, process production of reports , narratives and follow-ups of SAEs

    Independently perform CRF review, query generation and resolution againstestablish data review guidelines on Covance or client data management systems as assigned by manageament

    Assist with training of new employees, e.g. co-monitoring

    Coordinate designated clinical projects as local project coordinator ( with supervision) and may act as local client contact assigned

    Perform other duties as assigned by management

     

    Education/Qualifications

    Minimun Required:

    - University or collegue degree, or certification in a related allied health profession from an appropriately accredited institution ( e.g. nursing licensure)

     AND

    -  a minimum of 2 years of Clinical Monitoring experience

    Experience

    Minimun required:

    - UNiversity or college degree or certification in a related allied health proffession

     AND

    - a minimun of 2 years of Clinical Monitoring Experience

    - Ability to Monitor study sites independently according to the protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

    - Have a full understanding of a Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

    - Good planning, organization and problem solving abilities

    - Good communication and interpersonal skills

     - Good analytical and negotaiation skills

    - Computer competency

    - Fluent in local language and in English, both written and verbal

    - Work efficiently and effectively ina  matrix enviroment

    Preferred: One or more additional years of experience ina related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writting) is preferred

     

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