Clinical Trial Coordinator

Work Schedule

Environmental Conditions

Job Description

• 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.

• 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 sites 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.

• 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.

• 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.

• 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.

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.

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 youre organized detail-oriented motivated to learn and excited about developing your career in clinical research wed love to hear from you.

Apply today and help us deliver tomorrows breakthroughs.