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 critical-path development for rapid site activations
• Develop and review site lists and provide local input into site tiering for feasibility activities
• 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 to project leads
• Provide support for Activate and eTMF systems and maintain current databases
• Process documents sent to the client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study-specific documentation, training, access management, and activity-plan tracking
• Transmit documents to the client and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Work directly with sites to obtain site-selection documents
• Prepare regulatory compliance review packages and coordinate internal departments for site start-up
• Complete Site Interest Plans, collect investigator/site documents, and document site communications and survey follow-up
• Review survey data for completeness and logical responses
• Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and escalation
• Act as a local expert on site capacity and experience; identify and develop new 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

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• 0 to 1 year of previous comparable experience
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills; proficiency in MS Office (Word, Excel, and PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Ability to follow project work instructions accurately
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations and potential occasional travel required

• Fully remote work mode
• Standard Monday-Friday work schedule
• Potential occasional travel
• Training for new personnel and clinical training program
• Opportunity to support innovative clinical trials across global pharmaceutical and biotech clients