Unblinded CRA - Italy

Role Overview

We are seeking an experienced Unblinded CRA to support an ongoing clinical study in Italy. The successful candidate will be responsible for monitoring unblinded aspects of the study, with particular focus on investigational product (IP/IMP) activities, while ensuring the integrity of the study blind is maintained.

Unblinded CRAs monitor IP-related activities where investigational product information is not available in a blinded manner and are responsible for communicating potential unblinding risks appropriately.

Key Responsibilities

• Conduct unblinded monitoring activities at assigned investigational site(s).
• Monitor Investigational Product (IP/IMP)-related activities at site.
• Review IP accountability and associated study documentation.
• Work closely with relevant unblinded site personnel and maintain appropriate separation from blinded study activities.
• Identify, document and escalate potential risks of accidental or inappropriate unblinding.
• Verify that applicable unblinding procedures are conducted, recorded and reported in accordance with the study protocol, SOPs, Unblinding Monitoring Plan, ICH-GCP and applicable regulations.
• Support monitoring and oversight of site compliance with the clinical trial protocol and study procedures.
• Maintain accurate, timely and compliant monitoring documentation.
• Communicate effectively with study teams regarding monitoring findings, risks and required follow-up actions.
• Help ensure the rights, safety and well-being of clinical trial participants and the integrity of study data in line with GCP principles. European Medicines Agency describes ICH-GCP as the international standard covering clinical trial design, conduct, recording and reporting, with protection of participants and reliable trial data as key objectives.

Required Experience

• Previous experience working as a Clinical Research Associate (CRA).
• Strong clinical site monitoring experience.
• Experience with unblinded monitoring and/or blinded clinical trials highly desirable.
• Experience monitoring Investigational Product (IP/IMP) activities.
• Strong knowledge of ICH-GCP, clinical trial protocols and applicable regulatory requirements.
• Ability to work independently and confidently manage study-site responsibilities.
• Strong attention to detail and documentation skills.
• Excellent communication, organisation and site-management skills.
• Ability to identify and escalate compliance issues and risks that could compromise the study blind.