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 and review trial documents, distribute communications, and provide reports to internal team members
• Analyze and reconcile study metrics and findings reports
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Support meeting scheduling, local regulatory document tracking, RBM activities, documentation, access management, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Work directly with sites to obtain site-selection documents
• Assist with regulatory compliance review packages and site activation activities
• Complete Site Interest Plans in CTMS and collect associated investigator/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 to meet deadlines and manage site issues and risks
• Develop and enforce site contact and follow-up plans, escalating concerns or non-compliance
• Provide local expertise on site capacity, experience, tiering, and identification of new 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

• 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
• Proficient in MS Office (Word, Excel, and PowerPoint)
• Ability to obtain knowledge and master all 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 accurately follow project work instructions
• Ability to manage risk and perform risk escalation appropriately
• Occasional drives to site locations and potential occasional travel required

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training provided for new personnel and clinical training program