Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country, and investigator file reviews
• 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
• Document findings in appropriate systems and proactively communicate project risks
• Provide support for Activate and eTMF systems and maintain current databases
• Process and review eTMF documents, distribute mailings and communications, and provide reports to internal teams
• Analyze and reconcile study metrics and findings reports
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study-specific 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 with the activation critical path
• Complete Site Interest Plans in CTMS and collect associated investigator/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 to meet project deadlines and address site issues and risks
• Maintain site contact and follow-up plans and escalate non-compliance concerns
• Act as a local expert on site capacity and experience, recommend additional sites, and support local site tiering
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/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 providing the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
• Bachelor's degree preferred
• Ability to work in a team or independently as required
• 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) and ability to learn clinical trial database systems
• Ability to complete the organization's clinical training program
• Effective oral and written communication, interpersonal, judgment, decision-making, negotiation, risk-management, and work-instruction-following skills
• High self-motivation and positive attitude
• Occasional travel and drives to site locations may be required

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