Sso Expert Clinical Research Associate

Detalles de la oferta

.Site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites (from issue management to risk identification).Expert Clinical Research Associate (eCRA) is assigned to more complex trials and/or to less experienced sites. Role takes on the responsibility as SME (Subject Matter Expert) as needed and supports SSO Clinical Project Managers to ensure trials are executed per expected timelines. Supports development of more junior Clinical Research Associates in collaboration with CRA Manager and the implementation of innovative processes and technologies. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio. Can take on other delegated tasks for study level execution in collaboration with SSO Clinical Project Manager.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. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate- 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. Documentation according to GDP and Novartis standards.- Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements- Identify deficiencies in site process, work in close collaboration with site on risk mitigation- Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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