FSP 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 and eTMF systems and keep databases current
• Process documents for the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members
• Analyze and reconcile study metrics and findings reports
• Assist with resolving findings related to site documentation
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support study-specific translation materials and translation quality control
• Maintain knowledge of applicable SOPs, client directives, and regulatory guidelines
• Support client and internal meeting scheduling
• Review and track local regulatory documents
• Support risk-based monitoring activities
• Maintain study documentation and systems, including team lists, training requirements, system access, and project activity plans
• Transmit documents to the client and centralized IRB/IEC
• Maintain vendor trackers
• Support regulatory submissions
• Work directly with sites to obtain site-selection documents
• Assist with regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities with the site activation critical path
• Complete Site Interest Plans in CTMS and collect associated documents
• Document site communications, follow-ups, and survey responses in real time
• Review survey data for logical, complete, and relevant responses
• Collaborate with teammates to meet project deadlines and communicate site issues and risks
• Ensure site contact and follow-up plans are implemented and escalate concerns or 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 and 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
• Relevant education, training, and/or directly related experience may be considered as an equivalency in some cases
• 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, and 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
• Essential 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

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