CRA

About the role

**Please note this position can be based in Andalucía, Madrid or the North (País Vasco, La Rioja, Cantabria

The CRA is responsible 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).

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. 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
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.
Role Requirements

Required Experience
At least 1 year pharmaceutical industry experience or other relevant experience
Central/in-house monitoring or field monitoring experience is desirable
Functional Area

Research & Development

Division

Global Drug Development

Business Unit

GCO GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

No
Novartis

Fecha de publicación: 14/10/2023