Covance

  • Senior CRA - Client dediated, Copenhagen

    Job Location(s) DK-Copenhagen
    Job Number
    2018-24403
    Job Category
    Clinical Monitoring
    Position Type
    Full-Time
  • Job Overview

    Covance is actively recruiting a Senior CRA in Denmark, ideally to be based in the Copenhagen area.  This is a full time Client Dedicated role so the selected candidate will only be working on studies from a single sponsor!

     

    Key Duties:

    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 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

    +   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

     

    For more information please contact Andy Smith on +44 (0)1635 253 724 or send your CV to andy.smith@covance.com

    Education / Qualifications

    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 six months on-site monitoring (preferred)

    Valid Driver's License

    Experience

    • Field based, home office but willing to come into the Copenhagen office, when required
    • Previous monitoring experience in clinical trials, minimum 2 years
    • Proven skills in site management including site performance and patient recruitment
    • Excellent soft skills (include oral and written communication skills; computer literacy; works effectively in a matrix multicultural environment)
    • Good organizational and time management skills, able to work highly independently and be a team player
    • Flexibility, expected travelling ~2-3 days/week
    • Customer focus and right mind-set to meet client’s needs and skills in building relationship with customer.
    • Ability to set up priorities and handle multiple tasks simultaneously in changing environment
    • Fluent in English (verbal and written)
    • Location strong preference near Copenhagen 

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