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
• Provide system support for Activate and eTMF and keep databases current
• Process documents for Client (e)TMF, perform reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate and distribute Investigator Site File, pharmacy binder materials, and study supplies
• Support translation materials and translation quality control
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Support client and internal meeting scheduling, regulatory document tracking, and RBM activities
• Maintain study documentation, training records, system access, team lists, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Work with sites to obtain site-selection documents
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans and collect site documents when applicable
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and accurate responses
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Ensure site-contact plans are followed 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 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
• Previous experience comparable to 0 to 1 year
• Bachelor's degree preferred
• 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
• Knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
• Ability to successfully complete the organization's clinical training program
• Ability to follow project work instructions accurately
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations and potential occasional travel required

• Fully remote work arrangement
• Full-time employment
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support