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thermofisher·2 days ago

Clinical Trial Coordinator

Milan, ItalyHybridFull-timeMid · 2-5 yearsH1B likely

About this role

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.