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
• Aid development of site activation critical paths
• Develop and review site lists for feasibility activities and provide local input into 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 sent to the client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials, non-clinical supplies, and site distribution
• Support study-specific translation materials and translation quality control
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support client and internal meeting scheduling
• Review and track local regulatory documents
• Support risk-based monitoring activities
• Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and prepare regulatory compliance review packages
• Work with sites to obtain site-selection documents
• 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
• Ensure site-contact plans are implemented 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

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience comparable to 0 to 1 year
• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems accurately and efficiently
• Strong customer focus
• Flexibility to reprioritize workload to meet 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
• Good computer skills; proficiency 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 appropriate risk escalation
• Potential occasional travel required

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