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Freelance Country Submission Specialist, Turkey - Oferta z Jobs.pl

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Freelance Country Submission Specialist, Turkey

Nr ref.: /JOBS.pl

  • Job Title: Country Submission Specialist

    Location: Home-based, Turkey

    Contract: 6-months' contract, 1.0 FTE


    Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation, and provide updates of local processes and requirements to the Regulatory Intelligence portal.
    Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
    Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable)
    Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
    Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
    Complete review of essential documents following Essential Document Checklist QC.
    Arrange and review translations of relevant study documents.
    Provide regular local status updates to project lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems as required for assigned projects.
    Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
    Support other departments as necessary
    Identify site issues during start-up process, resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
    Train and mentor other associates on local regulations and internal procedures.
    Complete assigned training programs and apply learning.
    Complete necessary administrative tasks.
    May perform other duties as assigned.

    Minimum requirements

    Undergraduate degree or RN in a related field or equivalent combination of education, training and experience
    Two and one-half (2.5) years clinical research/monitoring experience including two (2) years study start-up experience
    Ability to learn and follow task-specific procedures, be attentive to detail and place importance on accuracy of information
    Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
    Strong organizational skills
    Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
    Ability to work with minimal supervision in a fast-paced environment with a sense of urgency to match the pace
    Must demonstrate good computer skills
    Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
    Occasional travel may be required

    For more information or to apply, please contact Magdalena Raczynska - Recruiter EMEA at for further information.


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