Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Support audit readiness by reviewing files according to SOP schedules and department guidance
• Support site activation activities and development of site activation critical paths
• Develop and review site lists for feasibility activities and contribute 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
• Ensure allocated tasks are completed on time, within budget and to quality standards
• Provide support for Activate, eTMF and other clinical trial systems
• Process documents for the Client eTMF, perform eTMF reviews, distribute communications and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolving site documentation findings
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support 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 maintenance of study documentation, team lists, training requirements and system access
• 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 completeness and logical consistency
• Collaborate with teammates and clinical personnel regarding site issues and risks
• Maintain plans for site contact and follow-up and escalate non-compliance
• Contribute local site capacity and experience knowledge to site recommendations and tiering
• 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
• Previous experience comparable to 0 to 1 year
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office (Word, Excel, and PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization’s clinical training program
• Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to analyze project-specific data and systems
• Ability to manage multiple tasks and changing timelines
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to follow project work instructions
• Negotiation skills
• Ability to manage risk and escalate appropriately
• Occasional drives to site locations; potential occasional travel required

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support
• Opportunity to act as a buddy during onboarding
• Professional and clinical training program