Covance

  • Clin Res Assoc II

    Job Location(s) MX
    Job Number
    2018-19516
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

     

    Cardiovascular, Vaccines, Dermatology, CNS and Respiratory.

    AREAS OF EXPERTISE

     Phase I- III Protocols

     GCP/ICH

     EDC (Inform, OC-RDC, and Medidata-RAVE)

     CTMS (E-Clinical, ICOTrial)

     Microsoft Office Proficiency

     PSV, SIV, SMV and COV

    EXPERIENCE

    Education/Qualifications

    Minimum Required:

     

    ¨ Position is located in Monterrey, Mexico

    ¨ External Candidates

    ¨ University or college 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.

    ¨ Internal Candidates

    ¨ Internal candidates with a minimum of 2 years of Clinical Monitoring experience

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

    ¨ Thorough knowledge of monitoring procedures

    ¨ Basic understanding of the clinical trial process

    Preferred:

    ¨ Thorough knowledge of Covance SOPs for site monitoring

    Experience

    Minimum Required:

     

    ¨ Position is located in Monterrey, Mexico

     

    ¨ External Candidates

    ¨ University or college 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.

    ¨ Internal Candidates

    ¨ Internal candidates with a minimum of 2 years of Clinical Monitoring experience

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

    ¨ Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up 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 office language and in English, both written and verbal

    ¨ Works efficiently and effectively in a matrix environment

    Preferred:

    One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

     

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