CRA (Level I)

Work Schedule

Environmental Conditions

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.

• 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.

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.

• This is a field-based clinical monitoring role requiring frequent travel to investigator sites typically around 6080% 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.

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

Youll 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.