CTC
Core
Administrative and technical support for clinical trial site activation, audit readiness, and regulatory compliance across global projects.
Role type
Junior Clinical Trial Coordinator (Site Activation & Regulatory Support)
Builds
Site activation critical paths, Investigator Site Files (ISF), regulatory compliance packages, and study documentation systems.
Domain
Clinical Research / Pharmaceutical Services
Required skills
Site selection and tiering, regulatory document review, (e)TMF management, study metrics analysis, local regulatory knowledge, risk escalation, system database maintenance, translation coordination
Preferred skills
Bachelor's degree, 0-1 years experience, local language proficiency
Technologies
Activate, eTMF, CTMS, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate site activation activities and develop critical paths; perform Country and Investigator file reviews; manage (e)TMF document processing and reviews; analyze and reconcile study metrics; support regulatory submissions and compliance review packages; liaise with Global Investigator Services; train new personnel on processes and systems.
Seniority
Junior, entry-level IC
