We are hiring Clinical Research Associates in Study & Site Operations within Global Drug Development (GDD). This is a site relationship management role to ensure sustainable trial execution at Site. The CRA performs on-site and remote monitoring activities related to initiation. They will 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. They will also be involved in 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.
About the Role
Responsibilities:
* Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
* Manage assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
* Perform Site Initiation Visit, ensuring site personnel is fully trained on all trial related aspects. Perform continuous training for amendments and new site personnel as required. Re-train site personnel as appropriate.
* Conduct continuous site monitoring activities (onsite and remote). Implement 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.
* Identify deficiencies in site processes and monitor site processes performed outside the site, working in close collaboration with site on risks mitigation and process improvements.
* 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.
* Perform Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
* Attend onboarding-, disease indication and project specific training and general CRA training as required.
* Proactively collaborate 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.
* Participate in audit organization and inspection readiness activities for monitoring and site related activities as required and ensure implementation of corrective actions within specified timelines.
* Collaborate with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry.
Requirements:
* Degree in scientific or healthcare discipline and ideally 1-2 years pharmaceutical industry experience or other relevant experience.
* Good knowledge of drug development process specifically clinical trial/research.
* Clinical and therapeutic knowledge.
* Central/in-house monitoring or field monitoring experience is desirable.
* Knowledge of international standards (GCP/ICH, FDA, EMA).
* Excellent time management and organization capabilities, including ability to prioritize and multi-task.
* Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
* Fluent in both written and spoken English. Excellent communicator and presenter, ability to influence others & Relationship management.
* Ability to manage sites independently; Proven ability to work independently with minimal supervision.
* A full UK driving license.
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