Overview
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.
Retribuzione / Benefits
- 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
Responsabilità
- 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
Requisiti fondamentali
- Master degree in health-related field
- CRA certification completed per DMC 15/11/2011
- 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
- Strong communication skills
- Presentation skills
- Cross-functional collaboration (implied)
- Microsoft Office
- Regulatory knowledge (GCP and SOPs)
- Data verification against case report forms
Experienced Clinical Research Associate (CRA) datore di lavoro: Medpace
L'azienda offre un ambiente di lavoro flessibile e competitivo, con un pacchetto retributivo attraente e opportunità di crescita professionale strutturate. I dipendenti possono beneficiare di eventi di apprezzamento sponsorizzati dall'azienda e iniziative per la salute e il benessere, il che contribuisce a una cultura lavorativa positiva e collaborativa. Questa posizione di Direttore Medico in Epatologia consente di avere un impatto significativo nella progettazione e nell'esecuzione di studi clinici a livello globale, rendendo l'azienda un datore di lavoro eccezionale per chi cerca un lavoro significativo e gratificante.
