Clinical Research Associate II
HybridTokyo, Tokyo, Japan
Job Summary
Conduct onsite monitoring visits, manage study startup, and perform CRF review and source document verification while resolving queries. Facilitate site budgets and contract negotiations, monitor trial progress at the country level, and maintain relationships with clinical sites and investigators. Act as a point of contact for in-house support services and vendors, communicating study progress to internal project teams. Support the regulatory team in preparing documents for study submissions and participate in feasibility research. Requires 2+ years of independent on-site monitoring experience in Japan, with proficiency in English and Japanese, and a hybrid schedule in Tokyo or Osaka.
Required Qualifications
- 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
- 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%
- Office is based in Japan. Tokyo or Osaka office (Hybrid)
Desired Qualifications
- Experience in feasibility assessment and study set-up process is preferable
- Experience in Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
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