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
• Communicate project risks proactively to project leads
• Provide system support for Activate and eTMF and keep databases current
• Process documents for the client eTMF, perform eTMF reviews, distribute communications, and provide 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
• Support translation materials and translation quality control
• Support client/internal meeting scheduling, 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-start-up activities
• Obtain site-selection documents directly from sites
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site activation activities with the critical path
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for completeness and logical consistency
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Manage site contact and follow-up plans and 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 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
• 0 to 1 year of previous relevant experience
• Good English language and grammar skills
• Proficient local language skills as needed
• 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
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Ability to work independently or as part of a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems
• Strong customer focus
• Flexibility to reprioritize workload according to changing project timelines
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Ability to manage risk and escalate risks appropriately

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support
• Opportunity to act as a buddy during onboarding
• Clinical training program
• Professional development through training in processes and systems