Clinical Trial Coordinator

• Coordinate, oversee, and complete assigned clinical 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
• Communicate project risks proactively to project leads
• Provide support for Activate, eTMF, and other clinical trial systems and keep databases current
• Process documents for the Client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members
• Analyze and reconcile study metrics and findings reports
• Assist with resolving findings related to site documentation
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Support client and internal meeting scheduling
• Review and track local regulatory documents where applicable
• Support risk-based monitoring activities where applicable
• Maintain study documentation and systems, including team lists, training requirements, system access, and project activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site start-up activities
• Work directly with sites to obtain site-selection documents
• Assist with regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the site activation critical path
• Complete Site Interest Plans and collect associated documents from investigators and site personnel where applicable
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates to meet project deadlines
• Communicate site issues and risks to the team and clinical personnel
• Ensure effective site contact and follow-up plans 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 account and contact information
• Contribute to global strategic 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
• Combination of appropriate education, training and/or directly related experience may be accepted as an equivalency
• Good English language and grammar skills
• Proficient local language skills as needed
• Proficient 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
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems for accuracy and efficiency
• Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Effective oral and written communication skills
• Essential judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Ability to work independently or as part of a team

• Fully remote work mode
• Standard Monday–Friday work schedule
• Training and onboarding support
• Opportunity to act as a buddy during onboarding
• Clinical training program
• Potential professional development through training in processes and systems