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
• 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-specific documentation, team lists, training requirements, system access, activity plans, and eTMF records
• Provide system support for GoBalto and eTMF
• Support risk-based monitoring activities
• Process trial documents, perform eTMF reviews, conduct mass mailings, and provide documents and reports to internal team members
• Schedule and organize client and 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 and 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 to sites
• Assist with study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required
• Provide administrative and technical support to the Project Team
• Act as a study lead or cross-functional liaison when required
• Support onboarding as a buddy and train new staff as needed
• Support departmental and cross-functional process improvement initiatives
• Occasional drives to site locations and potential occasional travel

• 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
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• 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 obtain knowledge and master all clinical trial database systems
• Ability to successfully complete PPD clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills
• In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient