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 system support for Activate and eTMF and keep system databases current
• Process documents for Client (e)TMF, perform (e)TMF reviews, distribute communications and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials and study supplies
• Assist with study-specific translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and regulatory guidelines
• Conduct on-site feasibility visits where applicable for Asia Pacific roles
• Support client and internal meeting scheduling
• Review and track local regulatory documents
• Support risk-based monitoring activities
• Maintain study documentation, team lists, training requirements, system access and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site start-up activities
• Obtain site-selection documents directly from sites
• Prepare regulatory compliance review packages
• Complete Site Interest Plans in CTMS and collect associated investigator/site documents
• 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 regarding deadlines, site issues and risks
• Ensure effective site contact and follow-up plans and escalate concerns or 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

Explore Clinical Trial Coordinator at Thermo Fisher Scientific. Review requirements and application details.

• 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 system support for Activate and eTMF and keep databases current
• Process documents for Client (e)TMF, perform reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate and distribute Investigator Site File, pharmacy binder materials, and study supplies
• Support translation materials and translation quality control
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Support client and internal meeting scheduling, regulatory document tracking, and RBM activities
• Maintain study documentation, training records, system access, team lists, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• 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 and collect site documents when applicable
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and accurate responses
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Ensure site-contact plans are followed and escalate concerns or 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 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