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