Clinical Research Associate II / Senior Clinical Research Associate

Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI Italy you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

Hybrid working arrangement in Milan area or homebased in other regions of Italy

Responsibilities:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions
• Prepare for and participate in audits and inspections

Qualifications

• University/College degree in Life Sciences or an equivalent combination of education, training & experience
• At least 2 years of independent on-site monitoring experience in Italy
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in Oncology / Gastroenterology therapeutic areas is a strong advantage
• Full working proficiency in English and Italian
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.