Clinical Trial Coordinator I

• 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 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 to project leads
• Support Activate and eTMF systems and keep databases current
• Process documents to client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate and distribute Investigator Site File, pharmacy binder materials, and non-clinical study supplies
• Support translation materials and translation quality control
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support meetings, regulatory document tracking, RBM activities, study documentation, training tracking, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Obtain site-selection documents directly from sites
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans 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 site issues and risks
• Maintain efficient site-contact and follow-up plans; 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 contact information
• Contribute to global feasibility processes and best practices
• Train new personnel in processes and systems
• Identify and develop new sites using local knowledge

• Bachelor's Degree preferred
• Approximately 3 years of clinical research experience preferred
• Strong verbal and written communication skills
• Practical experience with eTMF systems, preferably Veeva Vault
• Experience preparing accurate meeting minutes for large, cross-functional teams
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to analyze project-specific data and systems
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office, including Word, Excel, and PowerPoint
• Ability to complete the organization's clinical training program
• Judgment, decision-making, negotiation, risk management, and risk escalation skills
• Ability to follow project work instructions
• Occasional travel and drives to site locations may be required

• Fully remote work mode
• Standard Monday-Friday work schedule