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    cra i - São Paulo, Brasil - Fortrea

    Fortrea
    Fortrea São Paulo, Brasil

    há 1 semana

    Default job background
    Tempo integral
    Descrição

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

    With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

    Job Overview:

    Site monitoring and site management responsibility for clinical studies according to Company,
    and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the
    implementation of project plans, as assigned.


    Summary of Responsibilities:

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


    • Responsible for all aspects of site management as prescribed in the project plans.
    • General On-Site Monitoring Responsibilities.
    • Ensure the study staff who will conduct the protocol have received the proper materials and
    instructions to safely enter patients into the study.


    • Ensure the protection of study patients by verifying that informed consent procedures and
    protocol requirements are adhered to according to the applicable regulatory requirements.


    • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data
    collection tools by careful source document review.


    • Monitor data for missing or implausible data.
    • Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required
    monitoring tasks in an efficient manner, according to SOPs and established guidelines,
    including managing travel expenses in an economical fashion according to Fortrea travel
    policy.


    • Ensure audit readiness at the site level.
    • Travel, including air travel, may be required and is an essential function of the job.
    Qualifications (Minimum Required):


    • University or college degree, or certification in a related allied health profession from an
    appropriately accredited institution (e.g., nursing licensure). An equivalent amount of
    experience can be substituted as appropriate.


    • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
    • Basic knowledge of Regulatory Guidelines
    • Basic understanding of the clinical trial process
    • Fluent in local office language and in English, both written and verbal
    Experience (Minimum Required):


    • Six (6) months experience in a related role (e.g., site management, in-house CRA, study
    coordinator, research nurse, etc.)


    • Basic understanding of Regulatory Guidelines
    • Ability to work within a project team
    • Good planning, organization, and problem-solving skills
    • Good computer skills with good working knowledge of a range of computer packages
    • Works efficiently and effectively in a matrix environment
    • Valid Driver's License

    Preferred Qualifications Include:

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

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

    Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.

    Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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