Clinical Research Associate II

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. 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 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% 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.