Clinical Research Associate II
Core
Manage clinical aspects of full-service global projects in Japan, ensuring timelines, targets, and standards while building relationships with clinical sites and investigators.
Role type
Clinical Research Associate II (IC)
Builds
Clinical research projects across various therapeutic indications
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
On-site monitoring, study startup, CRF review, source document verification, query resolution, site budget management, contract negotiation, trial progress monitoring, site communication management, feasibility research, regulatory document preparation
Preferred skills
Feasibility assessment, study set-up process, Multiple Sclerosis, Inflammatory Bowel Disease, Oncology, Infectious Diseases
Technologies
MS Word, Excel, PowerPoint
Responsibilities
Conduct and report onsite monitoring visits, perform CRF review and source document verification, facilitate site budgets and contract negotiations, monitor trial progress on the country level, support regulatory team in preparing documents for study submissions
Seniority
Mid-level, hands-on IC
