CTA
Core
Provides administrative and technical support to clinical trial project teams, ensuring audit readiness, document management, and operational coordination across global trials.
Role type
Clinical Trial Assistant (CTA)
Builds
Clinical trial operations and documentation for global health research projects
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
document review and management, regulatory compliance (GCP), data analysis and reconciliation, system support (eTMF, GoBalto), vendor tracking, meeting coordination, translation support
Preferred skills
project matrix management, risk communication, study metrics analysis, ISF/Pharmacy binder coordination
Technologies
eTMF, GoBalto, MS Office (Word, Excel, PowerPoint), clinical trial databases
Responsibilities
Coordinate and complete assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time, within budget, and to high quality; maintain study-specific documentation and global support systems; support RBM activities; process documents for client (e)TMF and perform mass mailings; schedule meetings and prepare minutes; review and track local regulatory documents; transmit documents to client and IRB/IEC; analyze and reconcile study metrics and findings reports; maintain vendor trackers; assist with coordination of Investigator Site File (ISF) and Pharmacy binder materials; assist with study-specific translation materials and QC.
Seniority
Individual Contributor, entry to mid-level