Clinical Trial Coordinator

• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget and to a high-quality standard
• Provide support for Activate, eTMF and other clinical trial systems; maintain current databases
• Process documents for the Client (e)TMF, perform (e)TMF reviews, distribute communications and provide reports
• Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and applicable regulatory guidelines
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support client/internal meeting scheduling and tracking of local regulatory documents
• Support RBM activities and study-specific documentation, training requirements, system access and activity plans
• 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 with the project team
• Coordinate with internal departments to align site start-up activities with the activation critical path
• Complete Site Interest Plans in CTMS and collect associated documents when applicable
• Document communications, follow-ups and survey responses in real time
• Review survey data for logical, complete and relevant responses
• Collaborate with teammates and clinical personnel regarding deadlines, site issues and risks
• Maintain site-contact and follow-up plans; escalate concerns and 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 strategic feasibility processes and best practices
• Train new personnel in processes and systems
• Use local knowledge to identify and develop new sites