Clinical Research Associate II
PSI CRO · Tokyo
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.