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 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
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Provide support for Activate and eTMF systems and keep databases current
• Process documents to client eTMF, perform eTMF 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
• Support meetings, regulatory document tracking, RBM activities, study documentation, training tracking, system access, 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 and support regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans and collect associated investigator and site personnel documents when applicable
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and follow-up plans
• Act as a local expert on site capacity and experience and identify and develop 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
• Bachelor's degree preferred
• Previous experience comparable to 0 to 1 year
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• 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
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to follow project work instructions accurately
• Negotiation skills
• Ability to manage risk and perform risk escalation appropriately
• Occasional travel and drives to site locations may be required

• Fully remote work arrangement
• Standard Monday–Friday work schedule