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.

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