CRA (Level I)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 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.

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 Mi