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Clinical Trial Coordinator

Thermo Fisher Scientific -
Bologna, Emilia-Romagna

Candidati adesso

Dettagli della posizione

Tempo pieno

Qualifiche

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Inglese
Google Cloud Platform
Maturità
Competenze organizzative
Italiano

Descrizione completa della posizione

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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