As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the highest quality standards in the industry. This function operates at site and country level and can be assigned to projects as monitor or lead monitor.
Join the PSI team and help drive innovation and excellence in advancing healthcare solutions.
You will:
- Prepare, conduct and reports site selection, initiation, routine monitoring and close-out visits
- Perform CRF review, source document verification and query resolution
- Be responsible for site communication and management
- Act as a communication point between project teams and the site
- Leads project team calls on a country level
- Ensure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site level
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
- Prepare and participate in site audits and inspections
We have an office in both Tokyo and Osaka with hybrid work arrangement.
- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
- At least 3 years’ site monitoring experience at a CRA II or equivalent qualification level 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
- Therapeutic area experience in Oncology /Hematology /Gastroenterology (IBD) /Infectious Diseases /Neurology/Renal is a plus
- Full working proficiency in Japanese and Intermediate English
- 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%