Clinical Research Associate supporting and overseeing clinical trial sites to ensure quality and compliance. Seeking experienced candidates in Johannesburg or Cape Town.
About the role
- Clinical Research Associate ensuring compliance in clinical trials at Novo Nordisk. Managing monitoring visits and coordinating with research centers for effective communication.
Responsibilities
- Realizar visitas de monitoreo (inicio, seguimiento y cierre) para asegurar el cumplimiento de los protocolos y regulaciones vigentes
- Verificar la integridad y exactitud de los datos fuente y su correcta transcripción en los cuadernos de recolección de datos electrónicos
- Garantizar la adherencia estricta a las normas ICH-GCP y a las regulaciones locales de ANMAT en los centros de investigación
- Gestionar y mantener actualizados los archivos maestros de ensayos electrónicos (eTMF) y sistemas IVRS
- Identificar y reportar hallazgos críticos o desviaciones al protocolo, proponiendo acciones correctivas inmediatas
- Actuar como el contacto principal entre el patrocinador y el centro de investigación para asegurar una comunicación fluida
- Coordinar la logística de suministros del estudio y el manejo de muestras biológicas bajo estándares de calidad
Requirements
- Título universitario en Medicina, Farmacia, Biotecnología, QFB o carreras afines a la salud
- Mínimo de 2 años de experiencia comprobable como CRA
- Nivel de inglés intermedio a avanzado (esencial para plataformas globales y reportes)
- Sólido manejo de guías ICH-GCP, marco regulatorio argentino y plataformas eTMF/IVRS
- Disponibilidad para viajar dentro de la provincia de Buenos Aires dos veces al mes, incluyendo pernoctaciones
- Deseable: Certificación oficial de CRA y experiencia previa en monitoreo de fases II y III
Benefits
- Entorno de trabajo estimulante
- Oportunidades de desarrollo profesional continuo
- Contribuir a la innovación en el cuidado de la salud a nivel global
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
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