Alessandra Cappellano

• Reviewed and verified accuracy of clinical trial data, identifying discrepancies to ensure data integrity and compliance.
• Conducted qualification, initiation and monitoring visits to assess site performance and achieve agreed protocol standards.
• Conducted site visits to monitor compliance with protocol and overall clinical trial performance.
• Maintained internal systems with study site data to support performance monitoring and progress tracking.
• Prepared and presented comprehensive study progress reports at internal and external meetings to inform stakeholders and guide decision-making.
• Communicated regularly with sites to monitor study progress and achieve project expectations.
• Updated Investigator Site Files with current, accurate information, demonstrating compliance with Good Clinical Practice requirements.

Attended the following instructor led classroom training session of IQVIA Italy CRA Career Camp:

• General Clinical Research Topics:
• Methodology of Clinical Research;
• General Regulatory Framework and specifics for Italy;
• ICH-GCP;
• Overview of Interventional Study Activities: Site Selection, Site Initiation, Site Monitoring, Site Close out;
• Overview of Trial Master File, Investigator site file and document management;
• Review of local working instructions and procedures related to clinical studies. Completed on the job and in-house activities and gained deep insight on the following topics:
• Trial Master File management on interventional trials to verify compliance with relevant KPIs (Completeness, Timeliness, Quality);
• Submission and approvals of trials to Local Regulatory Authority and Ethics Committees for Amendments. Gained experience on study procedures by observing experienced clinical staff e.g. Clinical Research Associate (CRA), Clinical Lead (CL) and Clinical Trial Assistant (CTA) roles.
• Performed 20 days of monitoring activities shadowing expert monitors, including 10 days-on site and equivalent time spent for in-house monitoring activities.

• Checked counts and dosage accuracy on prescriptions before releasing medication to patients to avoid medical complications.
• Educated patients on proper dosage, administration and side effects of prescribed medication.
• Provided patient counselling regarding OTC medications.
• Resolved medication-related queries from patients and healthcare providers, offering clear, informative guidance.
• Established strong relationships with customers, fostering trust and loyalty.
• Managed pharmaceutical stock levels, placed orders, and organised inventory to maintain pharmacy efficiency.
• Analysed prescription trends and data to improve pharmacy services and patient satisfaction.
• Supported pharmacy manager in controlling costs by encouraging colleagues to operate within business requirements and initiatives.