Clinical Research Associate

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About the role

Job Description Summary 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.   Job Description • 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 • Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times • Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site. • 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 • Attends onboarding-, disease indication and project specific training and general CRA training as required • Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality Version: 1.0 Date: 1 Jan 2023 Author: SSO Implementation Team, led by Stephanie Visioli • Ensures that relevant site insights are shared with internal stakeholders such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites • Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines • Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry • Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date Education: • Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience). Languages: • Fluent in both written and spoken English and country language Experience/Professional requirement: • Up to 2 years pharmaceutical industry experience or other relevant experience • Central/in-house monitoring or field monitoring experience is desirable Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive

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