Covance

  • Clinical Research Associate I, Israel

    Job Location(s) IL
    Job Number
    2018-19803
    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, with or without guidance; liaise with vendors; and other duties, as assigned
    • Responsible for aspects of registry 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 Covance are spent wisely by performing theguidelines, including managing travel expenses in an economical fashion according to Covance travel policy
    • required monitoring tasks in an efficient manner, according to SOPs and established
    • Travel, including air travel, may be required and is an essential function of the job.
    • Prepare accurate and timely trip reports
    • Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management
    • Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
    • Provide coverage for clinical contact telephone lines, as required
    • Update, track and maintain study-specific trial management tools/systems
    • Generate and track drug shipments and supplies, as needed
    • Track and follow-up on serious adverse events as assigned
    • Implement study-specific communication plan as assigned
    • Attend investigators’ meetings, project team meetings and teleconferences, as needed
    • Assist Senior CRA in managing investigator site budgets
    • Perform other duties as assigned by management

    Education / Qualifications

    • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
    • a minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

    Experience

    • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
    • Ability to work within a project team
    • Good planning, organization and problem solving abilities
    • Good communication skills, oral and written
    • Good computer skills
    • Works efficiently and effectively in a matrix environment
    • Fluent in local office language and in English, both written and verbal

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