Clinical Research Associate II

PSI CRO AG · Tokyo, Japan · full-time · Hybrid · September 03, 2026

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Posted September 03, 2026 · Read from PSI CRO
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Job Description

We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Japan. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.

You will:

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup
  • Perform CRF review, source document verification and query resolution
  • Facilitate site budgets and contract negotiations
  • Monitor trial progress on the country level
  • 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

Qualifications

Office is based in Japan. Tokyo or Osaka office (Hybrid)

  • College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
  • Min. 2 years of independent on-site monitoring experience in Japan
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in feasibility assessment and study set-up process is preferable
  • Experience in Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
  • Full working proficiency in English and Japanese
  • PC skills to be able to work with MS Word, Excel and PowerPoint
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel up to 30% to 40%

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Employer
PSI CRO AG
Location
Tokyo, Japan · Hybrid
Contract
full-time