Clinical Trial Assistant Senior

hace 3 semanas


Madrid, España Sermes A tiempo completo

Clinical Trial Assistant Senior Lugar: Madrid
Tipo de Contrato: 6 meses – prórroga de 6 meses - Indefinido
Condiciones económicas: A convenir
Experiencia: 5 años
Idiomas: Inglés B2
Descripción Soporte en las gestiones administrativas necesarias para solicitar, hacer seguimiento y recibir resolución final en relación a las aprobaciones/autorizaciones para llevar a cabo la tramitación inicial de un estudio, así como modificaciones sustanciales de Investigación Clínica, de acuerdo a la legislación y/o PNTs aplicables en relación con CEICs, CEIm, AEMPS y CCAA, tales como: seguimiento telefónico, control de calidad de documentos, revisión de los aprobados, solicitud de documentación, generación de tablas de trazabilidad.
Actualización del REeC.
Preparación del TMF, ISF y archivo de farmacia.
Preparación y supervisión de los formularios necesarios para la puesta en marcha del estudio, así como las modificaciones sustanciales y notificaciones (Formulario de Solicitud Anexo 1 A (Xml), Formulario Modificación Sustancial, Formulario 1D, etc.).
Revisión y adaptación a la legislación aplicable de documentos generales del estudio.
Gestión de las tasas de evaluación necesarias (solicitud, seguimiento de factura y gestión de abono).
Soporte en la preparación del documento de respuestas a las aclaraciones de CEICs, CEIm, AEMPS y CCAA, así como la adaptación o implementación de cambios solicitados en los documentos esenciales del estudio (ej. HIP, cuestionarios, tarjeta de paciente) en coordinación con el equipo del Departamento de Investigación Clínica o Departamento de Calidad y Documentación asignado.
Preparación del transmittal form de los CRDs.
Formación Curso de CTA o experiencia en puesto similar de al menos 5 años.

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