Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to SOP schedules and department guidance
• Provide administrative support for site activation activities 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
• 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
• Maintain Activate, eTMF, CTMS, and other study systems and databases
• Process and review eTMF documents, distribute communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and study supplies
• Support translation materials and translation quality control
• Support client/internal meeting scheduling and local regulatory document tracking
• Support RBM activities and study documentation, training requirements, system access, and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers and support regulatory submissions
• Obtain site-selection documents directly from sites
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans in CTMS 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 site issues, risks, deadlines, and follow-up plans
• Act as a 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
• Contribute to identification and development of 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
• 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
• Strong customer focus
• Flexibility to reprioritize workload
• 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 drives to site locations; potential occasional travel required

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training for new personnel and clinical training program