Job Summary
* We are seeking a Clinical Research Associate to join our team.
About the Role
This is an exciting opportunity to work in a dynamic environment where you will be responsible for managing assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and our procedures.
Key Responsibilities
1. Site Management: Conduct Site Initiation Visits, ensuring site personnel are fully trained on all trial-related aspects. Provide ongoing training for amendments and new site personnel as required. Re-train site personnel as appropriate.
2. Monitoring Activities: Perform continuous site monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, ICH / GCP, global and local regulations including Health Authorities, IRB / EC, data privacy requirements, and global / local processes as applicable. Document according to GDP and our standards.
3. Risk Mitigation: Identify deficiencies in site processes and monitor site activities performed outside the site; collaborate closely with sites on risk mitigation and process improvements.
4. Culture of Compliance: Promote a culture of compliance, advocating adherence to the highest standards and ethical integrity, ensuring human subject protection and the reliability of trial results at all times.
5. Partnership Development: Establish strong partnerships and true collaboration with sites to increase patient enrollment and reduce issues.
6. Patient Flow: Engage early with sites on patient inventory and patient flow in advance of SIV, in close collaboration with the global and local study teams.
7. Site Closeout: Perform Site Closeout activities per SOPs and applicable regulations, ensuring sites are aware of follow-up activities and archiving requirements.
8. Collaboration: Collaborate proactively with the SSO Clinical Project Manager (CPM), CRA Manager, MSL, CRMA, and medical advisors to optimize recruitment, site development, and data quality.
9. Audit Preparation: Participate in audit organization and inspection readiness activities related to monitoring and site activities, ensuring timely implementation of corrective actions.
Qualifications
* Degree in Scientific disciplines.
* At least 1 year of experience as a CRA in a pharmaceutical company or CRO.
* Fluent in Italian. Good knowledge of English (B2 level).
* Willing to travel across Italy.
Benefits and Rewards
We offer a range of benefits and rewards to our employees, including opportunities for professional growth and development, a competitive salary and benefits package, and a positive and inclusive work environment.
Why Work With Us?
We are a leading healthcare company dedicated to improving and extending people's lives. We are committed to building an outstanding, inclusive work environment with diverse teams that represent the patients and communities we serve. If you are passionate about making a difference in the lives of others, we encourage you to apply for this exciting opportunity.
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