Experienced Regulatory Submissions Coordinator, Tokyo
Core
Coordinate regulatory submissions and site activation documents for clinical trials in the Japanese market.
Role type
Junior Regulatory Submissions Coordinator
Builds
Regulatory submission packages and site essential documents for clinical trials
Domain
Clinical Research / Life Sciences
Required skills
Regulatory document review, Informed Consent Form preparation, US Central IRB interaction, Local clinical regulations knowledge, Microsoft Office proficiency
Preferred skills
Pharmaceutical research experience, Clinical trial environment experience
Technologies
Microsoft Office
Responsibilities
Quality check on submission documents and site essential documents; Interaction with US Central IRBs, sites and international associates; Preparation and approval of informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges.