Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country, and investigator file reviews
• Provide administrative support for site activation activities and help develop 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
• Document review findings in appropriate systems
• Complete allocated tasks on time, within budget, and to a high-quality standard; communicate risks to project leads
• Support and maintain Activate, eTMF, CTMS, and other clinical trial systems and databases
• Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolving site documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Assist with translation materials and translation quality control
• Support client/internal meeting scheduling, local regulatory document tracking, RBM activities, and study documentation maintenance
• 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
• Complete Site Interest Plans, collect investigator/site documents, and document site communications and survey follow-up
• Review survey data for logical and complete responses
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Maintain efficient 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
• 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
• 0 to 1 year of comparable experience
• Relevant education, training, and/or directly related experience may be considered as an equivalency
• Ability to work independently or in a team
• Good organizational skills and strong attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems accurately
• Strong customer focus
• Flexibility to reprioritize workload
• 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
• Proficiency in Microsoft 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 with a 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
• Occasional drives to site locations and potential occasional travel required

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program