Responsabilidades
Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements.
Funcionar como um elo de ligação principal com investigadores clínicos/equipe do local.
Identificar, qualificar, iniciar, monitorar e fechar locais clínicos.
Co-monitorar com o CRO quando surgirem problemas com o site.
Assist in the selection and oversight of Contract Research organizations and other vendors.
Reviews adverse events and other data listings to identify issues with study conduct or compliance.
Assist with protocol and case report form development, drafts trail-related documents and operational procedures, collects regulatory documents, and maintains clinical files.
Requisitos
Bachelors degree, preferably in the Life Sciences, or a minimum of 3 years clinical research experience; incluindo 2 years site monitoring.
Experience with Phase I and/or bioequivalence studies and an understanding of GCP and ICH guidelines.
Must be willing to travel a minimum of 40% domestically/internationally as required.
Interessado em saber se os programas clínicos atuais, desenvolvimentos de pesquisa, ou abordagens terapêuticas emergentes podem ser relevantes para a sua situação?
Apenas informações educacionais e de pesquisa. As decisões médicas individuais devem ser tomadas em consulta com profissionais de saúde qualificados.
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