Clinical Trial Coordinator
Core
Administrative and technical support for clinical trial site activation, feasibility, and audit readiness across global pharmaceutical and biotech 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 / Biotechnology
Required skills
Site selection and tiering, regulatory document review, (e)TMF management, study metrics analysis, risk communication, SOP compliance, local market knowledge, translation coordination, vendor tracking, IRB/IEC submission support.
Preferred skills
On-site feasibility visit experience, RBM activities support, global strategic feasibility process development, new site identification.
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); ensure tasks are completed on time and within budget; process and review documents for client (e)TMF; 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; train new personnel on processes and systems.
Seniority
Junior to Mid-level, hands-on IC
