FSP Clinical Trial Coordinator I

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled department, internal, country and investigator file reviews
• Provide administrative support for site activation activities and help develop site activation critical paths
• Develop and review site lists for feasibility activities and contribute local input to site tiering
• Coordinate, oversee and complete assigned trial activities according to the task matrix
• Document file-review findings in appropriate systems
• Complete allocated tasks on time, within budget and to quality standards, escalating risks to project leads
• 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
• Assist with resolution of site-documentation findings
• Coordinate and distribute Investigator Site File, Pharmacy binder materials and study supplies
• Support translation materials and translation quality control
• Maintain knowledge of 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 and support regulatory submissions
• Work directly with sites to obtain site-selection documents
• Prepare regulatory compliance review packages
• Coordinate with internal departments to align site start-up activities
• Complete Site Interest Plans in CTMS 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 plans are followed and escalate concerns or non-compliance
• Contribute local expertise to site-capacity assessment, site recommendations and site 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
• 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 handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• 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
• 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
• Negotiation skills
• Ability to manage risk and perform risk escalation appropriately

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