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
• Provide administrative support for site activation activities and help develop 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
• Maintain and support Activate, eTMF, CTMS, and other clinical trial systems and databases
• Process and review eTMF documents, distribute communications, and provide documents and reports to internal teams
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials, study supplies, translations, and translation QC
• Support meetings, regulatory document tracking, RBM activities, study documentation, training tracking, and system access management
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Work directly with sites to obtain site-selection documents and coordinate site start-up activities
• Prepare regulatory compliance review packages
• Complete Site Interest Plans, collect investigator/site documents, and document site communications and follow-up
• Review survey data for logical and complete responses
• Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and escalation
• 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 and support onboarding
• Utilize local knowledge to identify and develop new sites

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Comparable previous experience of 0 to 1 year
• Good English language and grammar skills and 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 follow project work instructions accurately
• Ability to manage risk and perform risk escalation appropriately
• Occasional drives to site locations; potential occasional travel required

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