The Clinical Research Associate (CRA) ensures the sustainable execution of trials at the site level. They perform on-site and remote monitoring activities related to the initiation, conduct, and timely completion of Phase I-IV GDD trials within the country, adhering to monitoring procedures, ICH / GCP guidelines, local regulations, and SOPs.
The CRA proactively manages site performance (recruitment & quality) and identifies site needs and issues early. They serve as the primary point of contact (internally & externally) for all sites.
About the Role
Key Responsibilities:
* Act as the frontline liaison between Novartis and study sites to ensure successful collaboration, meeting milestones and deliverables with ownership mindset.
* Manage assigned study sites, conducting Phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
* Perform Site Initiation Visits, ensuring site personnel are fully trained on trial-related aspects, and provide ongoing training for amendments and new personnel.
* Conduct continuous site monitoring activities (onsite and remote), ensuring compliance with protocols, ICH / GCP, regulations, and documentation standards.
* Identify deficiencies in site processes and collaborate with sites on risk mitigation and process improvements.
* Promote a culture of compliance and ethical integrity, ensuring human subject protection and reliable trial results.
* Establish strong partnerships with sites to enhance patient recruitment and reduce issues.
* Engage early with sites on patient inventory and flow in collaboration with the global and local study teams.
* Perform Site Closeout activities per SOPs and regulations, ensuring proper archiving and follow-up.
* Collaborate proactively with the SSO Clinical Project Manager, CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
* Participate in audit preparations and inspection readiness activities, ensuring timely implementation of corrective actions.
Minimum Qualifications:
* Degree in Scientific disciplines.
* At least 1-year experience as a CRA in a pharmaceutical company or CRO.
* Fluent in Italian and proficient in English (B2 level).
* Willingness to travel across Italy.
Why join Novartis? Our purpose is to reimagine medicine to improve and extend lives. We value our people, who drive our success. Join us in this mission!
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