Covance

  • Clin Res Assoc II

    Job Number
    2018-20820
  • Education/Qualifications

    Required:

    • University/college 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 (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered

    • 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 S.O.P.s for site monitoring.

    Experience

    Required:

    • Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).

    In lieu of the above requirements, candidates with three (3) years of site management and/or study co-ordinator experience will be considered.

    • Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, 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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