• Clinical Research Associate I

    Job Location(s) DE
    Job Number
    Job Category
    Clinical Research Associate
    Position Type
  • Job Overview

    Responsible for all aspects of unblinded study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of initiation visits, liaise with vendors


    General On-Site Monitoring Responsibilities:

    • Ensure the study staff who will conduct the protocol have received the proper materials and instructions
    • Ensure the protection of study patients by verifying that IP is maintained, prepared, administered and handled correctly
    • Ensure the integrity of the data on data collection tools
    • Monitor data for missing or implausible data
    • Ensure the resources of the Sponsor and Covance 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 Covance travel policy
    • Travel, including air travel, may be required and is an essential function of the job.
    • Prepare accurate and timely trip reports
    • Review progress of projects and initiate appropriate actions to achieve target objectives
    • Interact with internal work groups to evaluate needs, resources and timelines
    • Act as contact for clinical trial supplies and other suppliers (vendors) 
    • follow-up on Quality Control Visits (CQC) 
    • Query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
    • Assist with training, mentoring and development of new employees, e.g. co-monitoring
    • Perform other duties as assigned by management

    Education / Qualifications

    degree in life sciences or equivalent experience in clinical research


    At least 1 year experience in monitoring clinical trials and/or unblinded CRA activities

    Fluent in German and Englisch (written and verbal)


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