
Trainee Clinical Research Associate
Há 2 dias
Job Description Título do Trabalho: Trainee Clinical Research Associate O Trainee Clinical Research Associate (Trainee CRA) deve adquirir competências e conhecimentos práticos na monitorização de ensaios clínicos através de formação em contexto de trabalho (on-the-job training) no Departamento de Ensaios Clínicos (GCTO-Portugal), nas seguintes áreas: Gestão de protocolos e centros de ensaio clínico, apoiando e sob-supervisão de Clinical Research Associates, atividades de monitorização on-site e remotas, incluindo visitas de validação, iniciação, ongoing e close-out.
Assegurar a conformidade com as Boas Práticas Clínicas (ICH-GCP), procedimentos, leis e regulamentos locais, bem como o protocolo do ensaio, plano de monitorização e documentos relacionados.
Monitorização remota da adequada implementação de ensaios clínicos (assegurar a fiabilidade dos dados recolhidos bem como a proteção dos direitos, segurança e bem-estar dos indivíduos), familiarizando-se para tal com a utilização de ferramentas e sistemas de gestão remota utilizados, sob supervisão de Clinical Research Associates.
Gestão de documentos essenciais, apoiando a preparação de Investigator e Trial Binders (físicos ou electrónicos).
Gestão de Qualidade, participando em acções internas regulares de controlo de qualidade e preparação de auditorias/inspecções, sob supervisão de Clinical Research Associates e/ou Country Clinical Quality Manager.
Competências Essenciais: Fluente em Português e em Inglês (oral e escrito), com excelentes competências de comunicação, incluindo a capacidade de compreender e apresentar informações técnicas de forma eficaz.
Boas competências informáticas (uso do MS Office) e capacidade de adaptação rápida a novas aplicações informáticas em diversos dispositivos.
Capacidade de compreender e analisar dados/métricas.
Conhecimento básico de investigação clínica e monitorização de ensaios clínicos (preferencial).
Competências Comportamentais: Espírito de aprendizagem contínua Abordagem proativa e criativa à resolução de problemas.
Boas competências interpessoais Orientação para objetivos Boa capacidade de trabalho em equipa Disponibilidade para viajar a nível nacional 40% - 60% do tempo de trabalho.
Requisitos Educacionais: Licenciatura em área científica/saúde (preferencial) Pós-graduação em Monitorização de Ensaios Clínicos ou formação equivalente (preferencial).
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