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
• Provide administrative support for site activation activities
• Aid 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 the task matrix
• Perform department, internal, country, and investigator file reviews and document findings
• Complete allocated tasks on time, within budget, and to quality standards; communicate risks
• Support Activate and eTMF systems and maintain current databases
• Process and review trial documents, distribute mailings and communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate Investigator Site File and Pharmacy binder materials and study supplies
• Support translation materials and translation quality control
• Support client/internal meeting scheduling and regulatory document tracking
• Support RBM activities and study documentation/system maintenance
• 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 internal departments to align site start-up activities with activation critical paths
• Complete Site Interest Plans and collect associated investigator/site documents when applicable
• 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 on deadlines, site issues, and risks
• Ensure site-contact and follow-up plans are implemented; escalate concerns and non-compliance
• Provide local expertise on site capacity and experience, recommend additional sites, and support site tiering
• 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
• Utilize local knowledge to identify and develop new sites

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