Senior Clinical Research Associate
HybridTokyo, Tokyo, Japan
Job Summary
Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits while performing CRF review, source document verification, and query resolution. Manage site communication and act as the liaison between project teams and sites, leading country-level project calls. Ensure subject recruitment targets are defined, communicated, recorded, and met, and that project timelines are followed at the site level. Participate in feasibility research and support the regulatory team in preparing documents for study submissions. Prepare for and participate in site audits and inspections. Requires a Life Sciences degree, three years of site monitoring experience in Japan, and full working proficiency in Japanese. Hybrid work available in Tokyo and Osaka with up to 40% travel.
Required Qualifications
- 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
- 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%
Desired Qualifications
- 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
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