Clinical Research Associate II

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.