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 quality standards; communicate risks to project leads and line manager
• Maintain study documentation, team lists, training trackers, system access management and project activity plans
• Keep the electronic Trial Master File (eTMF) up to date and provide GoBalto and eTMF system support
• Support risk-based monitoring (RBM) activities
• Process documents for the client eTMF, perform eTMF reviews, mass mailings and communications, and provide documents and reports to internal teams
• 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 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

• 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
• Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
• 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
• Excellent computer skills; proficiency in MS Office (Word, Excel, PowerPoint) and ability to learn clinical trial database systems
• Ability to successfully complete the PPD clinical training program
• Self-motivated, positive attitude and strong interpersonal skills
• Occasional driving to site locations and potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule