Clinical Research Associate Trainee Oncology

hace 2 semanas

Madrid, España Astrazeneca A tiempo completo

En AstraZeneca convertimos las ideas en medicamentos que cambian vidas. Trabajar aquí significa ser emprendedor, pensar en grande y trabajar juntos para hacer realidad lo imposible. Cada decisión que tomamos está basada en las posibilidades que la ciencia nos ofrece. Desde nuestros laboratorios hasta los departamentos de ventas o marketing, el equipo de AstraZeneca trabaja para potenciar que la ciencia cambie la vida de los pacientes.
Actividades generales Se espera que el aprendiz de CRA aprenda, domine y ejecute, según sea necesario, las siguientes actividades:
Completar las capacitaciones requeridas dentro de los plazos acordados.
Familiarizarse con la estructura del Protocolo de Estudio Clínico y cómo gestionarlo.
Proceso de desarrollo de formularios de consentimiento informado, tanto a nivel global como local, hasta su aprobación e implementación.
Proceso de identificación de centros potenciales y cómo realizar visitas de selección.
Plan de monitoreo y cómo asegurar que se siga.
Actividades de inicio del estudio y gestión del mantenimiento regulatorio.
Visitas de Calificación del Sitio, recopilación, preparación, revisión y seguimiento de documentos para el proceso de solicitud; presentación de la solicitud/documentos adecuados a EC/IRB y a las Autoridades Regulatorias para el inicio y durante la duración del estudio.
Visitas de Iniciación del Sitio acompañadas (preparación previa y carta de seguimiento y actividades posteriores).
Visitas de monitoreo del sitio acompañadas (preparación previa y carta de seguimiento y actividades posteriores).
Visitas remotas acompañadas (preparación previa y carta de seguimiento y actividades posteriores).
Visitas de cierre del sitio acompañadas (preparación previa y actividades de cierre posteriores).
Verificaciones de datos remotos: qué revisar y cómo documentarlo.
Gestión de formación y apoyo del sitio, incluidos los principios de Gestión de Calidad Basada en el Riesgo (RbQM).
Participación en reuniones de Investigadores (si se realizan en Madrid) y asistencia en la preparación de reuniones internacionales.
Proceso de resolución de consultas: cómo hacerlo de manera oportuna y brindar apoyo si es necesario.
Gestión de Eventos Adversos Graves y su notificación. Actividades de seguimiento.
Gestión de medicamentos a lo largo del ciclo del ensayo clínico (incluida la rendición de cuentas final de los medicamentos).
Asistencia a reuniones locales y globales y/o teleconferencias y aprender cómo estar preparado para ellas.
Herramientas de gestión de estudios: CTMS, RAVE, IVRS, herramienta SQRA, paneles de estudio, etc.
Gestión de documentos de estudio: cómo asegurar que los sitios estén siempre listos para inspección.
Archivos de estudio: eTMF e ISF: mantenimiento, actualización y seguimiento de la documentación. Preparación para inspección.
Apoyo administrativo al estudio si es necesario: escaneo, copiado y archivo.
Gestión de enmiendas del Protocolo de Estudio hasta su implementación.

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