Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team as a study lead and cross-functional liaison
• Coordinate and facilitate project activities and oversee administration on assigned projects
• Act as a buddy during onboarding and provide training to new staff
• Identify new training requirements
• Support process improvement, enhancement, implementation, and change management initiatives
• Aid development of the critical path for site activation and serve as a project-team escalation point
• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Perform department, internal, country, and investigator file reviews and document findings
• Ensure tasks are completed on time, within budget, and to quality standards; communicate risks
• Maintain study documentation, team lists, training trackers, system access, activity plans, and eTMF records
• Support risk-based monitoring activities
• Process documents, perform eTMF reviews, distribute communications, and provide reports
• Schedule client/internal meetings and complete meeting minutes
• Review and track local regulatory documents and support audit readiness and audit responses
• Transmit documents to clients and centralized IRB/IEC
• Analyze and reconcile study metrics and findings; resolve site-documentation findings
• Maintain vendor trackers and coordinate Investigator Site File, pharmacy binder, and study-supply materials
• Support translation materials and translation quality control
• Provide system support and keep clinical-trial databases current
• Liaise locally on submission activity in accordance with global strategy
• Maintain accurate trial-status information
• Develop client-affiliate relationships where applicable
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Train personnel, functional team members, investigators, and clients as requested
• Serve as an alliance-level lead for client integration and eTMF activities
• Support site activation through technical/administrative coordination, site agreements, budgets, essential documents, regulatory packages, and site communications
• Develop site lists and maintain investigator/site staff contact details
• Complete Site Interest Plans in CTMS and document site communications and survey responses
• Review survey data and collaborate to achieve response goals
• Plan and follow up on site contacts, escalating concerns or non-compliance
• Act as local expert on site capacity and experience and recommend sites
• Conduct physician and site-personnel interviews to obtain protocol-level input
• Resolve investigator queries and maintain account/contact information
• Contribute to global feasibility processes, best practices, and strategic feasibility initiatives
• Identify and develop new sites using local market knowledge
• Serve as subject matter expert on feasibility survey tools and contribute to future system releases

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