Monitor Clínico I

hace 1 mes


Guadalajara, México Grupo Nichos A tiempo completo

Importante laboratorio Nacional solicita para Guadalajara:
Monitor Clínico I
- Escolaridad: Licenciatura afín a ciencias de la salud (Titulado)
- Idioma: Inglés intermedio (Comprobable)

**Requisitos**:

- Manejo de Paquetería Microsoft Office (Word, Excel, Power Point) Intermedio
- Buenas prácticas Clínicas/ ICH Intermedio
- Conducción de Estudios Clínicos de Fases Clínicas I - IV Básico
- Comunicación verbal, interpersonal y escrita intermedio.
- Manejo de sitios clínicos Básico
- Manejo de CTMS, IWRS, eCRF, eTMF Básico
- Conocimiento de varias áreas terapéuticas incluyendo Oftalmología Básico
- Objetivo del puesto:
Asegura que los estudios clínicos Fase I, II, III o IV en centros de investigación locales o remotos sean conducidos, registrados, analizados y publicados de acuerdo con el protocolo, el plan de monitoreo, los procedimientos normalizados de operación del laboratorio, la Conferencia Internacional de Armonización de los requisitos técnicos para el registro de medicamentos de uso humano (ICH), las guías de Buenas Prácticas Clínicas (GCPs) y todos los requerimientos regulatorios aplicables, mediante el desarrollo y la conducción del monitoreo clínico. Garantiza la seguridad y los derechos de los participantes, así como la calidad y veracidad de los datos obtenidos con el fin de asegurar la obtención de resultados claros para comprobar la seguridad y/o la eficacia del medicamento en ensayo.

Principales **Responsabilidades**:

- Supervisa el desarrollo de estudios clínicos Fase I, II, III o IV patrocinados por el laboratorio y vigila que los derechos de los sujetos participantes en los estudios clínicos sean respetados y que su seguridad sea salvaguardada.
- Reporta el resultado de cada visita a los sitios de acuerdo a las métricas establecidas, resuelve los hallazgos, escala en tiempo y forma los problemas que se presenten de acuerdo a su impacto y actúa como línea directa de comunicación entre el centro de investigación y del Laboratorio.
- Asegura la contabilidad y el buen manejo del medicamento de estudio y comparadores durante toda la conducción del estudio clínico.
- Mantiene actualizadas las carpetas regulatorias de los centros de investigación y del Laboratorio.
- Es responsable de coordinar los pagos a investigadores.

Competencias:

- Analítico
- Actitud de servicio
- Proactivo
- Orientado a resultados.

Ofrecemos:
Sueldo Base $21,600.00

Fondo de Ahorro

Aguinaldo 30 días

Vacaciones 10 días y 50% prima vacacional.

Seguro de vida

SGMM Individual

Vales de despensa

Grupo Nichos... Confianza que genera resultados.


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