Clinical Trial Coordinator

• 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 a high-quality standard
• Communicate project risks to project leads and line manager
• Maintain study documentation, team lists, training trackers, system access, and project activity plans
• Keep the electronic Trial Master File (eTMF) up to date and document file review findings
• Provide system support using GoBalto and eTMF
• Process documents sent to the Client eTMF, perform eTMF reviews, mass mailings, communications, and provide reports
• Review and track local regulatory documents
• Transmit documents to clients and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of 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
• Coordinate and facilitate project activities; may serve as study lead and cross-functional liaison
• Buddy new staff during onboarding and provide training as needed
• Support departmental and cross-functional process improvement initiatives
• Occasionally travel to site locations

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree
• Previous experience providing the knowledge, skills, and abilities to perform the job preferred (comparable to at least 4 years)
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility and adaptability to reprioritize workload and meet 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)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete PPD clinical training program
• Self-motivated, positive attitude, and strong interpersonal skills

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