Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to SOP schedules and department guidance
• Provide administrative support for site activation activities and help develop site activation critical paths
• Develop and review site lists using local knowledge, organization systems, external site lists, and sponsor directives
• Contribute local input to site tiering and 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
• Ensure tasks are completed on time, within budget, and to quality standards; communicate risks to project leads
• Provide system support for Activate and eTMF and keep databases current
• Process documents to client eTMF, perform eTMF reviews, distribute communications, and provide reports to team members
• Analyze and reconcile study metrics and findings reports
• Assist with resolving site-documentation findings
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Maintain knowledge of applicable SOPs, client directives, and regulatory guidelines
• Support client/internal meeting scheduling, local regulatory document tracking, RBM activities, study documentation, training tracking, system access management, and project activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site-selection document collection
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the activation critical path
• Complete Site Interest Plans in CTMS and collect associated investigator/site documents when applicable
• 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
• Establish and monitor site-contact follow-up plans and escalate concerns or non-compliance
• Act as a local expert 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
• Contribute local knowledge to identify and develop new sites
• May conduct on-site feasibility visits in Asia Pacific

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience comparable to 0 to 1 year
• Relevant education, training, and/or directly related experience may be considered as an equivalency in some cases
• Ability to work in a team or independently
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload according to changing project timelines
• Working 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
• Proficient 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
• Self-motivated, positive attitude, and good interpersonal skills
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and perform risk escalation appropriately
• Occasional driving to site locations and potential occasional travel

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