Clinical Research Associate II

Company Description

PSI is a leading Contract Research Organization with more than 30 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

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
• 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

Why join PSI?

• PSI is a stable, privately-owned company, organically growing since 1995.
• We have an excellent reputation in the industry, having won the CRO Leadership awards several years in a row.
• Team collaboration is high on our agenda. Our aim is for employees to feel valued and heard in friendly and supportive teams.
• We offer extensive onboarding and mentorship programs, profound therapeutic area trainings, interactive soft-skills trainings.
• PSI CRAs have an opportunity to work with different Sponsors on a variety of therapeutic areas. 

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