Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Coordinate and facilitate project activities and potentially serve as a study lead
• Act as a cross-functional liaison for the project team
• Support onboarding as a buddy and train new staff as needed
• Support departmental and cross-functional process improvement initiatives
• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Support department, internal, country, and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Communicate project risks to project leads and line manager
• Maintain study documentation, team lists, training trackers, system access, and activity plans
• Keep the electronic Trial Master File (eTMF) up to date and perform scheduled file reviews
• Provide GoBalto and eTMF system support
• Process documents for the client eTMF, perform eTMF reviews, conduct mass mailings, and provide reports
• Review and track local regulatory documents
• Transmit documents to the client and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Assist with resolving site-documentation findings
• Maintain vendor trackers
• 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

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree
• At least 4 years of comparable relevant experience preferred
• 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 and adaptability to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Proficiency in MS Office, including Word, Excel, and PowerPoint
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the PPD clinical training program
• Self-motivated with a positive attitude and strong interpersonal skills

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Occasional travel to site locations
• Training during onboarding and opportunities to provide training to new staff
• PPD clinical training program
• Home office environment