Regulatory Submissions Coordinator (based in Beijing)
Core
Coordinate regulatory submissions and site activation activities for clinical trials in China.
Role type
Regulatory Submissions Coordinator (Study Start up)
Builds
Investigative site activations for clinical trials
Domain
Clinical Research / CRO / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory documentation preparation, Ethics Committee (EC) submission management, site activation coordination, GCP guidelines knowledge, document tracking
Preferred skills
Experience with Regulatory Agencies, query response formulation
Technologies
Microsoft Office
Responsibilities
Perform activities to activate investigative sites in all phases of clinical trials; Manage site GCP office and EC submission; Review and finalize essential documents for site activation; Act as main contact for EC related activities; Maintain direct contact with investigative sites during study start up and maintenance; Track submissions and ensure timely filing of documents
