CRA

Summary Supervisa los datos de los pacientes y la información relacionada con el estudio relacionada con los sitios de estudio clínico y la participación en los ensayos clínicos.
Garantiza que el investigador se adhiere a los protocolos de investigación, los requisitos reglamentarios y las buenas prácticas clínicas y proporciona información sobre el plan de validación de datos.
Proporciona un monitoreo oportuno y preciso de los datos del paciente y la información relacionada con el estudio de los documentos de origen, los registros de investigación y las visitas al sitio cuando corresponda.
Pueden monitorear los sitios de estudio y la selección de instalaciones de auditoría.
About the Role Main Accountabilities Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
Conducts continuous site monitoring activities (onsite and remote).
Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
Identifies deficiencies in site processes and monitor site processes performed outside the siteworks in close collaboration with site on risks mitigation and process improvements.
Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times.
Identify deficiencies in site process, work in close collaboration with site on risk mitigation.
Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team.
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
Experience/Professional requirement.
Up to 2 years pharmaceutical industry experience or other relevant experience Central/in-house monitoring or field monitoring experience is desirable Fast change adaptability to best partner & influencing with sites on fast changing landscape Ability to manage sites independently; Proven ability to work independently with minimal supervision Good analytical thinking Ability to anticipate potential issues and take appropriate actions with or without supervision Clinical and therapeutic knowledge knowledge of international standards (GCP/ICH, FDA,EMA) Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance)