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El CE apoyará, facilitará y coordinará las actividades diarias de investigación clínica del/de los estudio(s) y desempeñará un papel fundamental en la ejecución del estudio. El CE trabajará estrechamente con el IP, el Centro Coordinador de LaRed (LaRed\\-CC), otros sitio(s) participante(s), patrocinador(es) y otras entidades relacionadas con el estudio clínico.\n\n**FUNCIONES:** El Coordinador de Estudios es responsable de las actividades relativas al protocolo de LaRed en un sitio asignado. Aunque la seguridad y el bienestar del participante del estudio son, en última instancia, responsabilidad del IP, el CE debe trabajar estrechamente con el IP del centro para garantizar el bienestar de los sujetos. El CE lleva a cabo actividades relacionadas con el protocolo, específicamente asignadas de conformidad con el protocolo, las políticas institucionales, las Buenas Prácticas Clínicas (BPC) y los requisitos reglamentarios aplicables.\n\n**FUNCIONES Y RESPONSABILIDADES:**\n\n\nLas funciones y responsabilidades principales pueden incluir, aunque no se limitan a, lo siguiente:\n\n* Adquirir comprensión y mantener conocimientos actualizados exhaustivamente sobre los protocolos de LaRed.\n* Identificar cualquier preocupación o riesgo antes del inicio de un protocolo, junto con el IP.\n* Participar en toda la formación requerida para la iniciación de estudios y otros tema(s) asignado(s).\n* Participar en reuniones relacionadas con los estudios.\n* Trabajar con el IP, el equipo del sitio y el LaRed\\-CC para desarrollar y revisar documentos del protocolo para el sitio asignado, tales como Formularios de Consentimiento Informado (FCI), Procedimientos Operativos Estándar (POE), Manuales de Operaciones (MO) y cualquier otro documento relacionado con el estudio específico.\n* Supervisar las actividades del estudio para garantizar el cumplimiento de los protocolos y de todas las políticas locales, federales, estatales, reglamentarias e institucionales aplicables, así como de las políticas internacionales pertinentes cuando corresponda.\n* Coordinar la selección de los sujetos del estudio en el sitio asignado:\n* Identificar y reclutar sujetos adecuados de la población estudiada (también denominado proceso de selección de posibles sujetos del estudio), respetando en todo momento las directrices de las BPC.\n* Desarrollar y mantener los Procedimientos Operativos Estándar (POE) pertinentes, herramientas de estudio, listas de verificación, registros y otros documentos procedimentales específicos de los procesos de selección de sujetos del estudio del sitio asignado.\n* Gestionar y documentar adecuadamente cualquier reembolso financiero a los sujetos.\n* Ejecutar y mantener actualizadas las competencias técnicas relativas al diagnóstico y la observación de enfermedades infecciosas, incluidas las técnicas de biología molecular, serología y pruebas de antígenos.\n* Asistir en otras actividades relacionadas con el estudio de conformidad con las normativas y las BPC.\n* Asistir al IP en la preparación y presentación de los documentos del estudio de LaRed ante el Comité de Ética correspondiente y cualquier otra agencia reglamentaria pertinente, incluidas las presentaciones de nuevos protocolos y documentos conexos, informes de avance, enmiendas y documentos de cierre. Colaborar con el Centro Coordinador de LaRed (LaRed\\-CC) según sea necesario para preparar y presentar dichos documentos con éxito.\n* Mantener los registros requeridos de la actividad del estudio, incluidos, entre otros: formularios de registro de casos, registros de dispensación de medicamentos o cualquier otro formulario reglamentario considerado pertinente.\n* Apoyar las visitas de inicio del sitio y las visitas intermedias de supervisión según sea necesario:\n\t+ Trabajar con los investigadores del sitio, otros miembros del personal y el LaRed\\-CC para cumplir con los requisitos de inicio, implementación y cierre del estudio.\n\t+ Seguimiento del progreso del sitio conforme a los requisitos de activación, intermedios y de cierre del sitio.\n\t+ Resolver todos los problemas de forma oportuna, incluidas las desviaciones respecto al protocolo/reglamentarias y las discrepancias en los datos identificadas durante las visitas de supervisión.\n\t+ Asistir en la corrección de cualquier hallazgo negativo de forma oportuna, según sea necesario.\n\t+ Notificar todos los eventos adversos (EA) y problemas inesperados (PI) al IP del sitio; coordinar la notificación de EA y PI al LaRed\\-CC, al patrocinador del estudio, al Comité de Ética correspondiente y a cualquier otra agencia reglamentaria, en cumplimiento de las BPC, las normativas internacionales y nacionales, el protocolo del estudio y los procedimientos de LaRed.\n* Coordinar las operaciones de los estudios de investigación:\n\t+ Obtener el consentimiento informado apropiado con la documentación correspondiente del sujeto del estudio o de su tutor legal.\n\t+ Seleccionar, reclutar y retener a los sujetos del estudio.\n\t+ Programar las visitas de los sujetos y las actividades clínicas relacionadas según el protocolo.\n\t+ Seguimiento de los sujetos según lo requiera el protocolo.\n\t+ Implementar los procedimientos del estudio según la capacidad clínica y la formación recibida.\n\t+ Garantizar la recolección, el procesamiento y el envío adecuado de muestras biológicas.\n\t+ Contactar al laboratorio, al IP del sitio y al patrocinador respecto a problemas o incidencias en el laboratorio, según sea necesario.\n\t+ Recopilar y archivar los resultados del laboratorio, según sea necesario.\n\t+ Recopilar los datos de los participantes en los documentos fuente, según sea necesario.\n\t+ Garantizar la extracción exhaustiva y precisa de los datos de los documentos fuente en los Formularios de Registro de Casos (FRC) o en los Formularios Electrónicos de Registro de Casos (FREC).\n\t+ Garantizar que la recopilación de datos, la introducción de datos, las consultas sobre datos y las discrepancias se completen y aborden de forma oportuna.\n\t+ Desarrollar y mantener actualizados los POE y otros documentos procedimentales específicos del sitio asignado, según sea necesario.\n\t+ Garantizar la exactitud de las prácticas clínicas en las actividades del protocolo.\n\t+ Evaluar la seguridad del sujeto durante toda su participación en el estudio y supervisar a los sujetos respecto a EA y PI según corresponda.\n\t+ Comunicar al IP cualquier preocupación relacionada con los derechos, la privacidad o el bienestar del sujeto tan pronto como surjan dichas preocupaciones.\n\t+ Consultar con el IP sobre dudas acerca de la interpretación del protocolo, de cualquier documento relacionado, de los documentos fuente de los sujetos y del FRC/FREC.\n* Facilitar y coordinar la logística de los suministros y equipos específicos del sitio y del estudio asignados al sitio, en colaboración con el IP y el LaRed\\-CC:\n\t+ Coordinar la contabilidad financiera y la facturación de los suministros del estudio.\n\t+ Identificar y documentar los artículos que requieren aportación o autorización por parte de la institución anfitriona del sitio.\n\t+ Garantizar que se realicen correctamente la documentación y las autorizaciones correspondientes para los activos aportados/financiados por el patrocinador estadounidense, en colaboración con el LaRed\\-CC, quien coordina la logística de adquisición de dichos artículos. Dichos activos pueden incluir, aunque no se limitan a: congeladores, centrífugas, otros equipos de laboratorio, computadoras, impresoras, pruebas rápidas de influenza, pruebas de embarazo y diversos insumos para muestreo.\n* Mantener una comunicación abierta con todo el personal del sitio y con los colaboradores de LaRed, incluidos:\n\t+ El IP del sitio y\n\t+ El LaRed\\-CC\n\t+ El personal de apoyo del estudio, p. ej., administradores/gestores de datos, laboratorios y farmacias.\n* Participar en cualquier teleconferencia o reunión web de LaRed relevante o asignada según sea necesario, p. ej., llamadas específicas del estudio con los sitios y seminarios web de actualización formativa.\n* Coordinar la preparación para auditorías del sitio y los esfuerzos de mejora de la calidad:\n\t+ Colaborar con el IP, otros miembros del personal del sitio y el LaRed\\-CC para diseñar e implementar objetivos y planes de gestión de la calidad para los estudios.\n\n\nCuando el sitio asignado no tiene un 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