Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country, investigator, and eTMF file reviews
• Support site activation activities and develop critical paths for rapid site activation
• Develop and review site lists and provide local input to site tiering and feasibility activities
• Coordinate, oversee, and complete assigned trial activities according to task matrices
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Maintain Activate, eTMF, CTMS, study documentation, trackers, and related databases
• Process and transmit documents to client eTMF and centralized IRB/IEC
• Analyze and reconcile study metrics and findings, and assist with resolving site documentation findings
• Coordinate and distribute Investigator Site File, Pharmacy binder, study supplies, translation materials, and reports
• Support regulatory submissions and prepare regulatory compliance review packages
• Work directly with sites to obtain site-selection documents and coordinate site contact and follow-up
• Document communications, survey responses, site issues, risks, and escalation activities
• Support client and internal meetings, RBM activities, vendor tracking, system access, training tracking, and study team lists
• Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information
• Train new personnel and contribute to global feasibility processes and best practices
• 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
• Previous experience comparable to 0 to 1 year
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office, including 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 in a team
• Strong organization, attention to detail, multitasking, analysis, communication, negotiation, judgment, decision-making, and risk-management skills
• Ability to follow project work instructions and escalate risks appropriately
• Occasional driving to site locations and potential travel required

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support
• Opportunity to work with a global team supporting pharmaceutical and biotechnology clinical trials