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
• Support site activation activities and development of 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
• Complete allocated tasks on time, within budget, and to a high-quality standard; communicate risks to project leads
• Provide system support for Activate and eTMF and maintain current system databases
• Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolution of site documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and study supplies
• Support translation materials and translation quality control
• Schedule client and internal meetings as needed
• Review and track local regulatory documents
• Support risk-based monitoring activities
• Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans
• 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
• Complete Site Interest Plans and collect associated investigator/site documents
• 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 deadlines, site issues, and risks
• Maintain efficient site contact and follow-up plans and escalate non-compliance
• Contribute local expertise to site capacity assessment, site recommendations, and site tiering
• Resolve investigator queries and maintain account and contact information
• Contribute to global 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
• Bachelor's degree preferred
• Previous experience comparable to 0 to 1 year
• 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 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, including 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 accurately follow project work instructions
• Negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Occasional driving to site locations and potential occasional travel
• Equivalency through appropriate education, training, and/or directly related experience may be considered

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