Experienced Clinical Research Associate (Cra)

Medpace; Monza; In loco; EUR 55.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible work environment

Competitive PTO packages

Structured career paths with growth

Company-sponsored employee events

Employee health and wellness

Descrizione del lavoro

Medpace Italy is seeking a Clinical Monitor to perform site monitoring, qualification, initiation and closeout visits, ensuring protocol and regulatory compliance. Travel up to 60-80% nationwide is required, with comprehensive training provided.

This role sits within a global CRO focused on Phase I–IV development across diverse therapeutic areas. You will verify investigator qualifications, manage data integrity, and support site performance to drive successful trials.

Competenze

• Master degree in a health-related field.
• Previous experience as CRA.
• Willingness to travel 60-80% nationwide.
• Fluent in English.
• Fluent in Italian.
• Strong communication and presentation skills.

Mansioni

• Conduct qualification, initiation, monitoring and closeout visits at research sites in compliance with the protocol.
• Communicate with site staff (coordinators and investigators) to ensure SOP and GCP adherence.
• Verify investigator qualifications, training, facilities, laboratories, equipment and staff.
• Verify source data against case report forms and ensure proper documentation.
• Confirm eligibility of enrolled subjects and review regulatory documents.
• Oversee device/investigational product/drug accountability and inventory.
• Assess adverse events and related data for reporting.
• Evaluate patient recruitment and retention performance and suggest improvements.
• Prepare monitoring reports and follow-up letters with findings and corrective actions.

Conoscenze

English

Italian

Cross-functional collaboration

Regulatory knowledge

Strong communication

Formazione

Master degree in health-related field

Strumenti

Microsoft Office

Descrizione del lavoro

In this role you join Medpace's Clinical Monitoring team in Italy to perform site monitoring, qualification, initiation, and closeout visits while ensuring protocol and regulatory compliance. You will verify investigator qualifications, manage data integrity, and support site performance to drive successful clinical trials. Travel up to 60-80% nationwide is required, with comprehensive training provided. This position offers growth within a global CRO focused on Phase I–IV development and diverse therapeutic areas.

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol
• Communicate with site staff including coordinators and investigators to ensure alignment and adherence to SOPs, GCP, and regulatory requirements
• Verify investigator qualifications, training, facilities, laboratories, equipment, and staff
• Verify source data against case report forms; ensure proper documentation and communicate protocol deviations
• Confirm eligibility of enrolled subjects and perform regulatory document review
• Oversee medical device/investigational product/drug accountability and inventory
• Assess and verify adverse events and related data for accurate reporting
• Evaluate patient recruitment and retention performance and suggest improvements
• Prepare monitoring reports and follow-up letters with findings and corrective actions
• Master degree in health-related field
• Previous experience as CRA
• Willingness to travel up to 60-80% nationally
• Familiarity with Microsoft Office
• Fluent in English and Italian
• Strong communication and presentation skills would be considered a plus
• Cross-functional collaboration (implied)
• Microsoft Office
• Regulatory knowledge (GCP and SOPs)
• Data verification against case report forms