Clinical Trial coordinator II
Core
Provide administrative and technical support for clinical trial site activation, feasibility assessments, and regulatory compliance across global projects.
Role type
Clinical Trial Coordinator II (Central/Local)
Builds
Site activation critical paths, feasibility assessments, and regulatory compliance packages for pharmaceutical/biotech clients.
Domain
Clinical Research / Pharmaceutical
Required skills
Site activation coordination, regulatory document review, feasibility assessment, data analysis, stakeholder communication, SOP adherence, vendor management, site list development, translation support, system administration.
Preferred skills
Bachelor's degree, 2+ years of relevant experience, local market knowledge, presentation skills.
Technologies
eTMF, CTMS, Activate, MS Office (Word, Excel, PowerPoint), database systems.
Responsibilities
Coordinate assigned trial activities per task matrix; perform internal, country, and investigator file reviews; process documents for (e)TMF; track local regulatory documents; analyze and reconcile study metrics; maintain vendor trackers; assist with Investigator Site File (ISF) and pharmacy binder distribution; support site selection and development of site lists; conduct feasibility assessments with investigators; train new personnel; support regulatory submissions and RBM activities; maintain accurate trial status in databases.
Seniority
Mid-level, hands-on IC
