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.
Sign in
To continue your applicationor continue with email
By continuing you agree to our Terms & Privacy Policy.
![[R&D] Clinical Development Medical, Associate Director, Research and Development - Vaccines](https://pcdns.recruit.net/2.0/jobsapi/logos/11489_128x128.png)
