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 provide local input into 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
• Support Activate and eTMF systems and keep databases current
• Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Assist with translation materials and translation quality control
• Maintain knowledge of SOPs, client directives, and regulatory guidelines
• Support client/internal meeting scheduling, 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 prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the activation critical path
• Complete Site Interest Plans, collect investigator/site documents, document site communications, and review survey data
• Collaborate with teammates and clinical personnel on deadlines, site issues, risks, contact plans, and escalations
• Act as a local expert on site capacity and experience; recommend and tier sites using local knowledge
• 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 utilize 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
• Ability to work in a team or independently
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload according to changing project timelines
• Working 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 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
• Good negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Occasional travel and drives to site locations may be required

• Fully remote work mode
• Standard Monday–Friday schedule