FSP Clinical Trial Coordinator
Core
Administrative and technical support for clinical trial site activation, feasibility, and regulatory compliance across global projects.
Role type
Clinical Trial Coordinator (Site Activation & Feasibility)
Builds
Site activation critical paths, feasibility site lists, regulatory compliance packages, and study documentation systems.
Domain
Clinical Research / Pharmaceutical Services
Deliverable
client delivery
Required skills
Site selection and tiering, regulatory document review, (e)TMF management, study metrics analysis, SOP compliance, local market knowledge, document translation QC, vendor tracking, IRB/IEC submission support, risk escalation, team collaboration
Preferred skills
Bachelor's degree, 0-1 years experience, clinical trial database system proficiency, local language proficiency
Technologies
Activate, eTMF, CTMS, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate assigned trial activities per task matrix; perform file reviews (department, internal, country, investigator); process and review (e)TMF documents; analyze and reconcile study metrics; assist with ISF and pharmacy binder compilation; conduct on-site feasibility visits (Asia Pac); support regulatory submissions and compliance review packages; liaise with Global Investigator Services; train new personnel; contribute to global feasibility processes.
Seniority
Junior, hands-on IC