Clinical Trial Coordinator

• Provide administrative and technical support to the Project Team
• Coordinate and facilitate project activities and potentially serve as a study lead and cross-functional liaison
• Act as a buddy during onboarding and provide training to new staff as needed
• Support departmental and cross-functional process improvement initiatives
• 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 a high-quality standard
• Communicate project risks to project leads and line manager
• Maintain study documentation, team lists, training trackers, system access, activity plans, and the eTMF
• Provide GoBalto and eTMF system support
• Support risk-based monitoring activities
• Process documents, perform eTMF reviews, conduct mass mailings, communications, and provide reports
• Schedule and organize client/internal meetings and complete meeting minutes
• 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 clarification and resolution of site-documentation findings
• Maintain vendor trackers
• Assist with compilation and distribution of Investigator Site File and Pharmacy binder materials and study supplies
• Assist with study-specific translation materials and translation quality control
• Attend kickoff meetings and take notes when required

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility and adaptability to reprioritize workload and support 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
• Excellent computer skills; proficiency in MS Office (Word, Excel, and PowerPoint) and ability to master clinical trial database systems
• Ability to successfully complete the PPD clinical training program
• Self-motivated, positive attitude, and strong interpersonal skills
• Occasional drives to site locations and potential occasional travel

• Fully remote work arrangement
• Standard Monday-Friday work schedule