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
• Help develop critical paths for site activation
• Develop and review site lists for feasibility activities and provide local input into site tiering
• Coordinate 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
• Support Activate and eTMF systems and keep databases current
• Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with 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
• Schedule client and internal meetings as needed
• Review and track local regulatory documents as needed
• Support RBM activities and study-specific documentation and systems
• Transmit documents to the client and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site start-up activities
• Work with sites to obtain site-selection documents
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans in CTMS and collect associated investigator/site documents as needed
• 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
• Maintain site contact and follow-up plans and escalate 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