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 (Central or Local)
Builds
Site activation critical paths, Investigator Site Files (ISF), regulatory compliance packages, and feasibility plans for pharmaceutical/biotech clients.
Domain
Clinical Research / Life Sciences / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Regulatory guidelines knowledge (ICH GCP, country regulations), document management, data analysis and reconciliation, project coordination, risk management, MS Office proficiency, local market knowledge.
Preferred skills
Bachelor's degree, prior clinical trial experience (0-1 years), bilingual capabilities.
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 documents for (e)TMF; analyze study metrics; assist with ISF and pharmacy binder compilation; conduct on-site feasibility visits (Asia Pac); support regulatory submissions and site selection; train new staff; liaise with Global Investigator Services.
Seniority
Junior to Mid-level, hands-on IC
