- Location
- Italy - Milan - Building Y, Segreen Business Park, Via San Bovio 1/3 · Bologna, Italy · Rome, Italy
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Healthcare
- Education
- High School
- Source
- Workday
Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.