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Clinical Research Associate Trainee Oncology
hace 3 meses
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. ¿Qué son SDV y SDR?
- Actividades de inicio del estudio y gestión del mantenimiento regulatorio. Las tareas pueden incluir 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.
- Gestión de cartas de seguridad.
- Manejo y reporte de desviaciones del protocolo: CAPAS.
- Legislación aplicable relacionada con ensayos clínicos.
Requisitos, Habilidades y Competencias:- Buen conocimiento de las guías internacionales ICH-GCP, conocimiento básico de GMP/GDP y conocimiento de las regulaciones locales relevantes.
- Buen conocimiento médico y capacidad para aprender las áreas terapéuticas relevantes de AZ.
- Comprensión básica del proceso de desarrollo de medicamentos.
- Buen entendimiento de la Gestión de Estudios Clínicos, incluyendo monitoreo, manejo de medicamentos del estudio y gestión de datos.
- Excelente atención al detalle.
- Buenas habilidades de comunicación escrita y verbal.
- Buenas habilidades de colaboración e interpersonales.
- Buenas habilidades analíticas y de resolución de problemas.
Términos:- Duración: 1 año.
- Se trata de una posición de beca
- Ubicación: Madrid
AstraZeneca es una empresa que promueve la igualdad de oportunidades. AstraZeneca tendrá en cuenta a todas las personas que reúnan el perfil para el puesto sin discriminación por motivos de discapacidad, sexo u orientación sexual, embarazo o periodo de maternidad/paternidad, raza u origen (nacional o étnico), edad, religión o creencias, identidad de género, estado civil o pareja de hecho y/o cualquier otra característica protegida por ley. AstraZeneca sólo emplea personas con permiso de trabajo en el país o países donde se anuncia la posición.
