FSP Clinical Trial Coordinator I

• 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
• Provide system support for Activate and eTMF and keep databases current
• Process documents for Client eTMF, perform eTMF reviews, distribute communications and provide reports
• Analyze and reconcile study metrics and findings reports
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Support client and internal meeting scheduling
• Review and track local regulatory documents
• Support risk-based monitoring activities
• Maintain study documentation, team lists, training requirements, system access and activity plans
• Transmit documents to the client and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions and preparation of regulatory compliance review packages
• Work directly with sites to obtain site-selection documents
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans and collect associated investigator and site personnel 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 regarding site issues and risks
• Escalate concerns and non-compliance to management
• Provide local expertise on site capacity, experience and tiering
• 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
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Ability to work in a team or independently
• Good organizational skills and strong attention to detail
• Ability to analyze project-specific data/systems accurately and efficiently
• Strong customer focus
• Flexibility to reprioritize workload
• 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 (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
• Essential judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Ability to manage risk and perform risk escalation appropriately
• Occasional travel may be required

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