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Freelance Country Submission Specialist Germany - Oferta z Jobs.pl

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Freelance Country Submission Specialist Germany

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  • Freelance Country Submission Specialist, Germany

    Home based (6 months / 0.8 - 1.0 FTE)

    Job Description:

    * 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.
    * Complete necessary administrative tasks.
    * May perform other duties as assigned.

    * Train and mentor other associates on local regulations and internal procedures.
    * Complete assigned training programs and apply learning.

    Experience Required:

    * Previous experience in clinical research or monitoring; including 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

    Education Required:

    * Bachelor's Degree in life science, pharmacy, nursing or RN, Or equivalent clinical research experience


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