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 proactively to project leads
• Provide support for Activate, eTMF and other clinical trial systems and keep databases current
• Process documents for the client eTMF, perform eTMF reviews, distribute mailings and communications, and provide documents and reports to internal teams
• Analyze and reconcile study metrics and findings reports
• Assist with resolution of site-documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Follow applicable SOPs, client directives and regulatory guidelines
• Support client/internal meeting scheduling, local regulatory document tracking and RBM activities as applicable
• Maintain study documentation and systems, including team lists, training requirements, system access and activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and prepare regulatory compliance review packages
• Obtain site-selection documents directly from sites
• Coordinate with internal departments to align site start-up activities with the site activation critical path
• Complete Site Interest Plans and collect associated investigator/site documents as applicable
• Document site communications, follow-ups and survey responses in real time
• Review survey data for logical, complete and relevant responses
• Collaborate with teammates and clinical personnel to meet deadlines and address site issues and risks
• Establish and monitor site-contact and follow-up plans, escalating concerns and non-compliance to management
• Provide local expertise on site capacity and experience and recommend additional sites
• Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information
• Contribute to global feasibility processes and best practices
• Train new personnel in processes and systems
• Use local knowledge to identify and develop new sites

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• 0 to 1 year of previous comparable experience
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Ability to work independently or in a team
• Good organizational skills and strong attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload according to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office, including Word, Excel and PowerPoint
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Self-motivated, positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and perform risk escalation appropriately
• Occasional driving to site locations; potential occasional travel required

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