Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled file reviews according to SOPs and department guidance
• Support site activation activities and development of site activation critical paths
• Develop and review site lists for feasibility activities and contribute local input to site tiering
• Coordinate, oversee, and complete assigned trial activities according to task matrices
• Perform department, internal, country, and investigator file reviews and document findings
• Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads
• Support Activate and eTMF systems and keep databases current
• Process and review eTMF documents, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Coordinate Investigator Site File, Pharmacy binder, and non-clinical study supply materials
• Support translation materials and translation quality control
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Schedule client and internal meetings as needed
• Review and track local regulatory documents
• Maintain study documentation, team lists, training requirements, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and prepare regulatory compliance review packages
• Work with sites to obtain site-selection documents
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans and collect associated investigator and site personnel documents
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates and clinical personnel to meet deadlines and resolve site issues and risks
• Manage site contact and follow-up plans and escalate concerns or non-compliance
• Provide local expertise on site capacity and experience and recommend additional sites
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
• Contribute to global feasibility processes and best practices
• Train new personnel in processes and systems
• Use local knowledge to identify and develop new sites

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