Clinical Research Associate Senior
3 days ago
We are seeking an experienced Senior Clinical Research Associate to join our team in Italy. As a Senior Clinical Research Associate, you will be responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, ensuring compliance with sponsor's procedural documents, international guidelines, and local regulations.
Key Responsibilities:- Assess the qualification of potential investigative sites and initiate clinical trials at investigative sites.
- Review and verify accuracy of clinical trial data collected, either on site or remotely.
- Provide regular site status information to team members and trial management.
- Complete monitoring activity documents as required by SOPs or other contractual obligations.
- Evaluate site and trial-related issues and escalate them per SOPs until identified issues are resolved or closed.
- Perform essential document site file reconciliation and source document verification.
- Verify SAE reporting according to trial specifications and ICH GCP guidelines.
- Communicate with investigative sites and facilitate audits and audit resolution.
- Undertake other reasonably related duties as may be assigned from time to time.
- Undergraduate degree or its international equivalent in a clinical, science, or health-related field from an accredited institution.
- 4 or more years of clinical monitoring experience mandatory.
- Previous experience in monitoring oncology studies would be an advantage.
- Experience in monitoring all trial components (pre-study site visit to closeout visit) preferred.
- Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
We offer a competitive salary, a range of health insurance options, and a comprehensive benefits package, including annual leave entitlements, retirement planning, and a global Employee Assistance Programme. We are committed to providing an inclusive and accessible environment for all candidates and employees.
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We are proud of our diverse workforce and the work we've done to become a more inclusive organization. We are dedicated to providing an inclusive and accessible environment for all candidates and employees.
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