Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to organizational SOPs and department guidance
• Provide administrative support for site activation activities
• Assist in developing the site activation critical path
• 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
• Ensure allocated tasks are completed on time, within budget and to quality standards
• Provide system support for Activate and eTMF and maintain current databases
• 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 study supplies
• Assist with translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and regulatory guidelines
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study documentation/system maintenance
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site selection document collection
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Document site communications, follow-ups and survey responses in real time
• Review survey data for completeness and logical consistency
• Communicate site issues and risks and escalate concerns or non-compliance
• Act as local expert on site capacity and experience and recommend additional 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
• Identify and develop new sites using local knowledge

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• 0 to 1 year of comparable experience
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems accurately
• Strong customer focus
• Flexibility to reprioritize workload
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• 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
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Negotiation skills
• Ability to manage risk and escalate appropriately
• Occasional drives to site locations and potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program