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.

What youll 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.

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.

Travel and working environment

• 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.

Why join us

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.

Employment Type : Full-Time
Experience: years
Vacancy: 1