Clinical Research Associate II

Company Description

PSI is a leading Contract Research Organization with almost 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 II at PSI 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.

You will:

• Conduct and report SSV, SIV, RMV, COV onsite monitoring visits
• 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 and particiapte on audits and inspections

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 2 years of independent on-site monitoring experience in Romania
• Experience in all types of monitoring visits in Phase II and/or III
• Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology is a plus
• Full working proficiency in English and Romanian
• 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

What We Offer:

• Stability, long-term cooperation
• Permanent contract, full-time job
• Hybrid or home-based work setting
• Competitive salary and benefit package
• Career development 
• Unique combination of team collaboration and independent work
• Friendly and supportive colleagues
• Onboarding courses about clinical research industry
• Mentoring and on-the job training
• Comfortable and well-established modern office

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