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 ontime 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 inhouse 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

  • CollegeUniversity degree in Life Sciences or an equivalent combination of education, training & experience
  • At least 2 years of independent onsite monitoring experience in Portugal
  • Experience in all types of monitoring visits in Phase II andor III
  • Therapeutic area experience in Oncology Hematology Gastroenterology (IBD) Infectious Diseases Neurology is a plus
  • Full working proficiency in English and Portugeese
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problemsolving skills
  • Ability to travel

  • Additional Information

    What We Offer:

    • Stability, longterm cooperation
    • Permanent contract, fulltime job
    • Hybrid or homebased 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 onthe job training
    • Comfortable and wellestablished 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.