Ethics Submission Specialist (Clinical Research)
Core
Coordinate ethics and governance submissions for clinical trials to ensure effective and timely approval and implementation.
Role type
Administrative specialist for clinical trial ethics submissions
Builds
Ethics and governance submissions for diverse clinical trial portfolios
Domain
Clinical research / Healthcare administration
Deliverable
client delivery
Required skills
project management, conveying complex medical information, compliance with ethics/governance guidelines, document review, status monitoring
Preferred skills
coordination of human research ethics applications, knowledge of medical terminology/scientific language
Technologies
None stated
Responsibilities
Prioritize tasks and balance competing deadlines; convey and interpret complex medical information to various audiences; ensure compliance with ethics and governance components (ICH-GCP, ethics offices, sponsors); lead review and management of detailed scientific documents; monitor status and progression of concurrent submissions
Seniority
Entry-level to Mid-level, hands-on IC