Clinical Research Associate II

PSI CRO·Tokyo or Osaka, Japan

Share role

Add a personal message

Email WhatsApp ↗

The recipient sees their own assessment. Your profile and score are not shared.

Role link

About the role

Hybrid Clinical Research Associate II role based in Tokyo or Osaka, Japan. The position manages clinical operations for global projects, including onsite monitoring, study start-up, CRF review, source data verification, query resolution, site management, feasibility work and regulatory submission support. Requires at least two years of independent onsite monitoring experience in Japan, Phase II/III experience, and full working proficiency in English and Japanese.

Key requirements

• College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
• At least 2 years of relevant experience
• Required skills: Independent on-site clinical monitoring in Japan, Monitoring visits in Phase II and/or III trials, Clinical study start-up, CRF review, Source document verification, Query resolution, Site communication and management, Trial progress monitoring, Feasibility research, Regulatory submission document support, MS Word, Excel and PowerPoint, Planning and multitasking, Communication, collaboration and problem-solving, Ability to travel up to 30% to 40%
• Required languages: English, Japanese

Opportunity details

• Workplace: Hybrid
• Posted: Sep 3, 2026
• Original advert language: English

Full vacancy

HealthRoleIQ regularly verifies this opportunity against the employer’s posting and highlights the details relevant to your match.

See original vacancy ↗

Job title: Clinical Research Associate II

Location: Tokyo/Osaka, Japan

Employment type: Full-time

Company Description

PSI is a leading Contract Research Organization with more than 30 years of experience 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

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.