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
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
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.