PSI CRO

Global CRO delivering on-time patient enrollment

Senior Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeOsaka, JapanNo salary listed

About the Job

Requirements

A college or university degree in Life Sciences or Pharmacy, RN qualification, or an equivalent combination of education, training, and experience.
At least 3 years of site-monitoring experience at CRA II or an equivalent qualification level in Japan.
Experience conducting all types of monitoring visits in Phase II and/or Phase III studies.
Full working proficiency in Japanese and intermediate proficiency in English.
PC skills sufficient to work with Microsoft Word, Excel, and PowerPoint.
Ability to plan and multitask in a dynamic team environment.
Communication, collaboration, and problem-solving skills.
Ability to travel up to 30%–40%.

Responsibilities

Prepare, conduct, and report site-selection, initiation, routine-monitoring, and close-out visits.
Perform case report form review, source document verification, and query resolution.
Manage communications with study sites.
Act as a communication point between project teams and study sites.
Lead project-team calls at the country level.
Ensure subject-recruitment targets are timely defined, communicated, recorded, and met, and that project timelines are followed at site level.
Participate in feasibility research.
Support the regulatory team in preparing documents for study submissions.
Prepare for and participate in site audits and inspections.

Desired Qualifications

Experience in feasibility assessment and the study set-up process is preferable.
Therapeutic-area experience in oncology, hematology, gastroenterology (IBD), infectious diseases, neurology, or renal is a plus.

Job Description

As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor.

Join the PSI team and help drive innovation and excellence in advancing healthcare solutions.

You will:

Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Act as a communication point between project teams and the site
Leads project team calls on a country level
Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
Participate in feasibility research
Support regulatory team in preparing documents for study submissions
Prepare and participate in site audits and inspections

Qualifications

We have an office in both Tokyo and Osaka with hybrid work arrangement.

College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level 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
Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus
Full working proficiency in Japanese and Intermediate English
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

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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