Job Description 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.
Job Description
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
Skills Desired
Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences