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 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
• Provide system support for Activate and eTMF and maintain current system databases
• Process documents for the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolving findings related to site documentation
• Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Maintain knowledge of applicable SOPs, client directives and regulatory guidelines
• Support client/internal meeting scheduling, regulatory document tracking, RBM activities, study documentation, training requirements and system access management
• 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 with the activation critical path
• 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, logic and relevance
• Collaborate with teammates and clinical personnel to address site issues and risks and meet project deadlines
• Plan and execute site contact and follow-up, escalating non-compliance to management
• Provide local expertise 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
• 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
• 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 as part of 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, 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
• Self-motivated with a positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and escalate risks appropriately
• Occasional driving to site locations and potential occasional travel

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel/site visits
• Training and onboarding support
• Professional development through clinical training program