Clinical Trial Coordinator

• Provide administrative and technical support to the clinical trial project team
• Support audit readiness through scheduled file reviews in accordance with SOPs and department guidance
• Support site activation activities and development of site activation critical paths
• Develop and review site lists for feasibility activities and provide local input into site tiering
• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Perform department, internal, country and investigator file reviews and document findings
• Complete allocated tasks on time, within budget and to quality standards; communicate risks to project leads
• Provide support for Activate, eTMF and other clinical trial systems and keep databases current
• Process documents for client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports
• Analyze and reconcile study metrics and findings reports
• Assist with resolving site documentation findings
• Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Assist with translation materials and translation quality control
• Maintain knowledge of SOPs, client directives and applicable regulatory guidelines
• Support client/internal meeting scheduling, regulatory document tracking and RBM activities as applicable
• Maintain study documentation, team lists, training requirements, system access and project activity plans
• Transmit documents to clients and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and site selection document collection
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans and collect associated investigator/site documents
• 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 on deadlines, site issues and risks
• Ensure site contact and follow-up plans are implemented and escalate non-compliance
• Act as a local expert 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
• Previous experience comparable to 0 to 1 year
• 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 accurately
• 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 complete the organization's clinical training program
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Occasional driving to site locations
• Potential occasional travel

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