Summary
This is a site relationship management role to ensure sustainable trial execution at site. The CRA will perform on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV GDD trials within Spain in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Responsible for 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.
Location: Madrid: Provincial.
About the Role
Key responsibilities but not limited to:
* 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 visits, ensures site personnel is fully trained on all trial related aspects.
* Perform continuous training for amendments and new site personnel as required.
* Conduct continuous site monitoring activities (onsite and remote).
* Implement site management activities to ensure compliance with protocol, global and local regulation including Health Authorities, data privacy requirements, global and local processes as applicable.
* Identify deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements
* Promote 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
* Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
* 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
Essential criteria:
* Degree in scientific or healthcare discipline
* Up to 2 years pharmaceutical industry experience or other relevant experience Central / in-house monitoring or field monitoring experience is desirable
Desirable criteria:
* Decision capability
* Excellent time management and organization capabilities, including ability to prioritize and multi-task
* Risk based mindset (from issue management to risk identification) supported by Novartis systems
* Early adopter and open mindset across borders to support one study approach Good knowledge of drug development process specifically clinical trial/research 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)
Languages:
* Fluent in both written and spoken English and country language
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Division
Development
Business Unit
Development
Location
Spain
Site
Madrid Provincial
Company / Legal Entity
ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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