Clinical Trial Coordinator

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation** =========================================================================================== **What You'll Do** ------------------ ### Clinical Trial & Documentation Support * Coordinate and complete assigned clinical trial activities in accordance with the study task matrix. * Perform Country and Investigator file reviews and document findings in the appropriate systems. * Support audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures. * Ensure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads. * Process and maintain clinical trial documentation within the electronic Trial Master File (eTMF). * Review eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation. * Analyze findings reports and assist with the clarification and resolution of site documentation findings. * Support the preparation, compilation, and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies. * Assist with study-specific translations and translation quality control, as required. ### Site Activation & Regulatory Support * Provide administrative support for site activation and start-up activities. * Work with internal teams to help ensure site start-up activities remain aligned with the site's activation critical path and project timelines. * Support regulatory submissions and the tracking of local regulatory documentation. * Transmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable. * Maintain accurate and timely records of site communications, contact attempts, follow-ups, and survey responses. * Review survey information to help ensure responses are complete, accurate, and relevant. * Support effective site follow-up plans and escalate concerns or potential risks appropriately. * Liaise with relevant internal teams to support the timely resolution of investigator queries. ### Systems & Study Coordination * Provide support for clinical trial systems such as **Activate, eTMF**, and other study platforms. * Help ensure study databases and systems remain accurate and up to date. * Maintain study-specific documentation, team lists, project training requirements, activity plans, and vendor trackers. * Support Risk-Based Monitoring (RBM) activities where applicable. * Assist with scheduling internal and client meetings as required. * Support study communications, including document distribution, reports, and project-specific mailings. * Collaborate closely with project team members to achieve targeted study milestones and deadlines. * Communicate site-related issues and potential risks to appropriate clinical and project colleagues. **What We're Looking For** -------------------------- ### Minimum Qualifications * High school/secondary school diploma or equivalent relevant academic or vocational qualification. * Additional university-level education in **life sciences, healthcare, or a related discipline** is an advantage. * Previous relevant experience may be beneficial; however, candidates who demonstrate the appropriate knowledge, skills, and motivation to develop within clinical research may also be considered. * Equivalent combinations of education, training, and directly related experience may be considered. ### Preferred Skills & Experience * Strong organizational skills and excellent attention to detail. * Ability to manage multiple tasks efficiently while working to project deadlines. * Ability to analyze project-specific information and systems to ensure accuracy and completeness. * Strong customer-focused mindset. * Flexibility and adaptability to changing priorities and study timelines. * Interest in developing a strong working knowledge of **ICH-GCP**, applicable Italian and European regulations, and clinical research procedures. * Good written and spoken **English**, together with proficiency in the local language as required. * Effective written and verbal communication skills. * Strong interpersonal skills and the ability to collaborate effectively with cross-functional and international teams. * Good computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint. * Ability to quickly learn and confidently work with clinical trial databases and systems. * Good judgment, problem-solving, and decision-making skills. * Ability to follow study-specific procedures and project instructions accurately. * Ability to identify potential risks and escalate them appropriately. * Self-motivated with a positive and proactive approach to work. * Ability to work effectively both independently and as part of a team. **Working Environment & Travel** -------------------------------- This position is primarily performed in an **office and/or home-office environment**, depending on business requirements. * Regular travel is not a core requirement of the role. * Occasional travel or driving to clinical trial sites may be required depending on study needs. * The position provides exposure to a wide range of clinical trial activities, systems, and cross-functional teams, supporting continued development within clinical research. **Why Join Thermo Fisher Scientific?** -------------------------------------- When you join Thermo Fisher Scientific, you become part of a global team committed to accelerating scientific discovery and improving patient outcomes. We offer: * An excellent opportunity to **build and develop your career in clinical research**. * Exposure to international clinical trials and global project teams. * Hands-on experience across site activation, regulatory documentation, clinical trial systems, and study management activities. * A collaborative and inclusive environment where you can learn from experienced clinical research professionals. * Continuous learning, professional development, and opportunities for career progression. * Competitive compensation and benefits. * The opportunity to contribute to clinical research that can make a meaningful difference in patients' lives. If you're organized, detail-oriented, motivated to learn, and excited about developing your career in clinical research, we'd love to hear from you. **Apply today and help us deliver tomorrow's breakthroughs.**