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
Apply on company website Tokyo, Japan Remote (Global) Full-time
PSI CRO is hiring a Clinical Research Associate II
About company
PSI is a leading full-service global Contract Research Organization (CRO). The company specializes in delivering pivotal Phase 2 and Phase 3 clinical trials on time and on budget, with predictable patient enrollment across multiple therapeutic areas.
PSI focuses on a wide range of therapeutic areas including Oncology, Gastroenterology (GI), Hematology, Cell and Gene Therapy, Neurology, Infectious Diseases, Radiopharmaceuticals, and Respiratory diseases, among others.
The company leverages advanced platforms like Visional for clinical trial feasibility analysis and Synetic for site intelligence and study acceleration, aiming to protect trials from delays and budget overruns through data-driven solutions.