Clinical Trials Educator
hace 2 semanas
El Clinical Trial Educator (CTE) es responsable de capacitar y apoyar al personal del sitio, equipos clínicos y pacientes involucrados en ensayos clínicos. Este rol garantiza que todos los participantes comprendan los protocolos del estudio, los requisitos regulatorios y los procedimientos necesarios para una ejecución exitosa del ensayo.
**Responsabilidades principales**:
- **Capacitación y educación**:
Brindar formación inicial y continua a investigadores y coordinadores de investigación clínica sobre protocolos, Buenas Prácticas Clínicas (GCP) y normativas regulatorias. Realizar visitas de iniciación de sitio y sesiones de actualización según sea necesario.
- **Apoyo a pacientes**:
- **Soporte al estudio**:
Acompañar a los sitios durante las fases de inicio, reclutamiento y seguimiento del estudio. Evaluar necesidades formativas y proporcionar apoyo personalizado. Preparar a los sitios para auditorías, inspecciones y visitas del patrocinador.
- **Cumplimiento regulatorio**:
Asegurar que todas las actividades educativas cumplan con GCP, directrices ICH y regulaciones aplicables (FDA, EMA, entre otras). Apoyar la implementación de acciones correctivas en caso de desviaciones.
- **Colaboración interdisciplinaria**:
Trabajar de manera conjunta con los Clinical Trial Managers (CTMs), Investigadores Principales (PIs) y equipos de calidad para alinear prioridades formativas y objetivos del estudio. Servir de enlace entre patrocinadores y personal del sitio.
- **Desarrollo de recursos educativos**:
Crear y mantener materiales didácticos específicos del estudio, como manuales, presentaciones, preguntas frecuentes y videos instructivos. Adaptar los recursos según el feedback recibido.
- **Documentación y reportes**:
Mantener registros precisos de todas las actividades de capacitación y educación. Elaborar informes sobre la efectividad de los entrenamientos, preparación de los sitios y métricas de participación de pacientes.
**Requisitos**:
- Experiência comprobada en investigación clínica, educación clínica o funciones relacionadas.
- Conocimiento profundo de GCP, ICH y normativas regulatorias internacionales.
- Excelentes habilidades interpersonales, organizativas y de comunicación.
- Disponibilidad para viajar según los requerimientos del estudio.
Tipo de puesto: Tiempo completo
Idioma:
- Inglés (Obligatorio)
Lugar de trabajo: Empleo presencial
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