Clinical Trial Assistant
Core
Support the operational management of international clinical studies, including study coordination, documentation management, and regulatory support.
Role type
Clinical Trial Assistant
Builds
International clinical studies
Domain
Healthcare / Clinical Research
Required skills
eTMF management, Investigator Site Files (ISF) management, ICH-GCP guidelines knowledge, study start-up support, feasibility analysis, regulatory submission support, meeting organization, cross-functional collaboration
Preferred skills
Recent ICH-GCP certification
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Manage Sponsor Trial Master Files (eTMF) and essential study documentation; Support preparation and maintenance of Investigator Site Files (ISF); Contribute to study feasibility and site selection; Assist with regulatory submissions to authorities and ethics committees; Support study start-up and site activation; Organize study meetings and draft minutes; Ensure compliance with ICH-GCP requirements.
Seniority
Mid-level, hands-on IC
