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Covance Sweden is looking for Senior Clinical Research Associate! (hom - Oferta z Jobs.pl

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Covance Sweden is looking for Senior Clinical Research Associate! (hom

Nr ref.: /JOBS.pl

  • About the job:

    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; 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:

    o Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
    o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
    o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
    o Monitor data for missing or implausible data
    o 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

    Prepare accurate and timely trip reports
    Manage small projects under direction of a Project Manager/Director as assigned
    Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned
    Review progress of projects and initiate appropriate actions to achieve target objectives
    Organize and make presentations at Investigator Meetings
    Participate in the development of protocols and Case Report Forms as assigned
    Participate in writing clinical trial reports as assigned
    Interact with internal work groups to evaluate needs, resources and timelines
    Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
    Responsible for all aspects of registry management as prescribed in the project plans
    Undertake feasibility work when requested
    Conduct, report and follow-up on Quality Control Visits (CQC) when requested
    Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
    Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
    Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    Independently perform CRF review; 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
    Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
    Perform other duties as assigned by management

    About You:

    University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
    Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    Thorough understanding of the drug development process
    Fluent in local office language and in English, both written and verbal
    Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
    Strong experience within oncology
    In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
    Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    Advanced site monitoring skills
    Advanced study site management skills
    Advanced registry administration skills
    Ability to work with minimal supervision
    Good planning and organization skills
    Good computer skills with good working knowledge of a range of computer packages
    Advanced verbal and written communication skills
    Ability to train and supervise junior staff
    Ability to resolve project-related problems and prioritizes workload for self and team
    Ability to work within a project team
    Works efficiently and effectively in a matrix environment


    Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.


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