Clin Ops Delivery Associate III
Core
Senior Clinical Trial Coordinator providing administrative and technical support for clinical trial activities, ensuring tasks are completed on time, within budget, and to high quality standards.
Role type
Senior Clinical Trial Coordinator (Central or Local)
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Pharmaceutical Trials
Deliverable
client delivery
Required skills
Clinical trial database systems, (e)TMF management, regulatory document review, study metrics analysis, vendor tracker maintenance, ISF/Pharmacy binder coordination, translation QC
Preferred skills
Bachelor's degree, 4+ years of relevant experience, knowledge of ICH GCP and country regulations
Technologies
GoBalto, eTMF, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; Perform department, internal, country, and investigator file reviews; Ensure tasks are performed on time, within budget, and to high quality standards; Support maintenance of study-specific documentation and global support systems; Provide system support for GoBalto and eTMF; Support RBM activities; Process documents for client (e)TMF and perform mass mailings; Schedule and organize client/internal meetings; Review and track local regulatory documents; Transmit documents to client and centralized IRB/IEC; Analyze and reconcile study metrics and findings reports; Maintain vendor trackers; Assist with coordination of Investigator Site File (ISF) and Pharmacy binder materials; Assist with study-specific translation materials and QC
Seniority
Senior, hands-on IC