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 provide training to new staff as needed
• 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
• 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 for the client eTMF, perform eTMF reviews, mass mailings, communications, and reporting
• Schedule and organize client/internal meetings and prepare 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 Investigator Site File and Pharmacy binder materials and study supplies
• Support study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years
• Bachelor's degree preferred
• Ability to work in a team or independently
• Strong organizational skills and attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility and adaptability to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, 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, positive attitude, and strong interpersonal skills
• Occasional drives to site locations and potential occasional travel required

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Potential occasional travel
• Training and onboarding support
• Opportunity to support process improvements and cross-functional initiatives