CRA (Level I)

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

We are looking for a Clinical Research Associate I (CRA I) to join our clinical operations team in Italy.

As a CRA I, you will perform and coordinate clinical monitoring and site management activities across investigator sites. Working through a combination of on-site and remote monitoring, you will help ensure that clinical trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements and standard operating procedures (SOPs).

You will act as a key point of contact for investigational sites, helping safeguard participants’ rights, safety and well-being while supporting the quality, integrity and reliability of clinical trial data.

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What you’ll do

- Monitor investigator sites using a risk-based monitoring approach, conducting on-site and remote monitoring activities in accordance with the approved monitoring plan.
- Perform source data review (SDR), source data verification (SDV) and case report form (CRF) review, as applicable, to support data quality and integrity.
- Assess site compliance with the study protocol, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
- Apply critical thinking, root cause analysis and problem-solving techniques to identify site-level issues and support appropriate corrective and preventive actions.
- Review investigational product accountability through physical inventory and associated records, as required.
- Document monitoring observations clearly and accurately in reports and follow-up correspondence within required timelines.
- Identify and escalate significant issues and deficiencies to clinical management and follow actions through to resolution.
- Maintain regular communication with investigational sites between monitoring visits, as required, to support protocol compliance, timely data entry and resolution of outstanding issues.
- Conduct site initiation, routine monitoring and close-out activities in accordance with relevant procedures and project requirements.
- Ensure essential study documentation is complete, accurate and maintained in accordance with ICH-GCP and applicable regulatory requirements.
- Conduct investigator site file reviews in line with project specifications.
- Participate in investigator meetings and, where required, support the identification and assessment of potential investigator sites.
- Maintain accurate and timely study information in relevant systems, including the Clinical Trial Management System (CTMS).
- Provide study status updates and progress reports to project teams as required.
- Facilitate effective communication between investigational sites, sponsors and internal project teams.
- Support responses to sponsor requirements, audits, regulatory inspections and other quality activities.
- Participate in investigator payment processes, where applicable.
- Complete administrative activities, including timesheets and expense reports, accurately and on time.
- Contribute to project initiatives, study tools and continuous process improvement activities.

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About you

You will bring a strong scientific background together with clinical research experience and an interest in developing your career in clinical monitoring.

You will have:

- A degree in Life Sciences, Pharmacy, Medicine or another relevant scientific discipline, together with appropriate academic and/or professional qualifications.
- Relevant clinical research and monitoring experience, typically equivalent to approximately 2 years of clinical monitoring experience .
- A working knowledge of ICH-GCP and the ability to develop and maintain knowledge of applicable clinical trial regulations, procedures and study documentation.
- An understanding of clinical trial monitoring and risk-based monitoring principles.
- Basic medical and therapeutic area knowledge, with a good understanding of medical terminology.
- Strong organisational and time-management skills, with the ability to manage multiple priorities effectively.
- Good critical-thinking and problem-solving skills, including the ability to investigate issues and identify appropriate root causes and solutions.
- Strong interpersonal skills and the ability to build effective relationships with investigator sites, medical professionals, sponsors and internal colleagues.
- Good written and verbal communication skills.
- A collaborative approach, with the ability to work effectively both independently and as part of a team.
- Strong attention to detail and a commitment to quality.
- Good computer skills, including Microsoft Office, with the ability to learn and work confidently with clinical trial systems and software.
- Good written and spoken English.
- A valid driving licence, where required for the role.

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Travel and working environment

- This is a field-based clinical monitoring role requiring frequent travel to investigator sites, typically around 60–80% , depending on study and business requirements. Travel may include overnight stays.
- Depending on the investigator site and study requirements, appropriate personal protective equipment (PPE), such as protective eyewear, garments or gloves, may be required.

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Why join us?

At Thermo Fisher Scientific, you’ll join a global organisation where your work can directly contribute to the development of new and potentially life-changing therapies.

You’ll collaborate with experienced clinical research professionals, work across diverse studies and therapeutic areas, and have opportunities to develop your clinical monitoring expertise and career within a global organisation.

Our teams are united by a shared commitment to quality, collaboration and our Mission – to enable our customers to make the world healthier, cleaner and safer.

Join us and help shape the future of clinical research.