Clinical Trial Coordinator

• 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 project risks proactively to project leads
• Provide support for Activate, eTMF and other clinical trial systems
• Keep system databases current
• Process documents sent to the Client eTMF, perform eTMF reviews, distribute mass mailings and provide documents and reports
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of site documentation findings
• Coordinate, compile and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Assist with study-specific 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 risk-based monitoring activities and study-specific documentation and systems
• Transmit documents to the client and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site start-up activities
• Obtain site-selection documents directly from sites
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the critical path
• Complete Site Interest Plans in CTMS and collect associated investigator/site personnel 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 and risks
• Maintain an efficient site-contact and follow-up plan, escalating concerns or non-compliance
• Act as 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 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
• Bachelor's degree preferred
• 0 to 1 year of comparable experience
• 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 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 successfully 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
• Negotiation skills
• Ability to manage risk and perform risk escalation appropriately
• Occasional drives to site locations; potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program