CTA
Core
Provides administrative and technical support to clinical trial project teams, ensuring audit readiness, document management, and process improvements.
Role type
Administrative and Technical Support Specialist (Clinical Research)
Builds
Clinical trial documentation, study metrics reports, and regulatory compliance files for global clinical research projects.
Domain
Life Sciences / Clinical Research / Contract Research Organization (CRO)
Required skills
Document review and management, regulatory compliance knowledge (GCP, ICH), data analysis and reconciliation, project coordination, system support (eTMF, GoBalto), translation coordination, meeting administration
Preferred skills
Bachelor's degree, 2+ years of relevant experience, proficiency in MS Office, ability to work independently or in a team, adaptability to changing timelines
Technologies
eTMF, GoBalto, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate and oversee 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; schedule meetings and prepare minutes; review and track local regulatory documents; transmit documents to client and IRB/IEC; analyze and reconcile study metrics; maintain vendor trackers; assist with ISF and Pharmacy binder materials; support study-specific translation and QC.
Seniority
Mid-level, hands-on IC
