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.