Clinical Trial coordinator II
Core
Provide administrative and technical support for clinical trial site activation, feasibility assessments, and audit readiness for pharmaceutical and biotech clients.
Role type
Clinical Operations Delivery Associate II (Clinical Trial Coordinator)
Builds
Site activation plans, feasibility assessments, regulatory compliance packages, and study documentation for global clinical trials.
Domain
Clinical Research / Pharmaceutical / Biotechnology
Deliverable
client delivery
Required skills
Site activation coordination, feasibility assessment, regulatory document review, (e)TMF management, data analysis and reconciliation, vendor tracking, study metric analysis, SOP compliance, local market knowledge development, training support.
Preferred skills
Bachelor's degree, 2+ years of relevant experience, knowledge of ICH GCP and country regulations, proficiency in MS Office.
Technologies
(e)TMF, CTMS, Activate, eTMF systems, MS Office (Word, Excel, PowerPoint)
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; perform file reviews (department, internal, country, investigator); process and review documents for (e)TMF; develop and review site lists for feasibility; support site activation critical path and start-up activities; analyze and reconcile study metrics; train new personnel; liaise with Global Investigator Services; support regulatory submission preparations.
Seniority
Mid-level, hands-on IC
