Freelance Country Submission Specialist Germany Nr ref.: /JOBS.pl 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 Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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