Senior Clinical Research Associate / Clinical Research Associate II (Clinical Research)

Location: Italy

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.

What you will do

• Deliver accurate and timely clinical monitoring reports for sponsor approval.
• Monitor clinical trial sites remotely, onsite, or through another approved monitoring mode, with a focus on data integrity and patient safety.
• Plan daily study-monitoring activities and prioritize work by site.
• Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits.
• Maintain TMF/eTMF records according to filing guidelines and organizational processes.
• Review site documents for accuracy, completeness, currency, and required updates, and manage monitoring-related expenses.

Requirements

• Undergraduate degree or international equivalent in a clinical, science, or health-related field, a registered nursing or other licensed healthcare qualification, or equivalent work experience.
• Previous clinical research experience and completion of a CRA training program.
• At least 4 years of clinical-trial experience for the Senior CRA level or at least 2 years for the CRA II level.
• Required CRA certification, qualifications, and training records in accordance with the Italian Decree.
• Knowledge of essential clinical-trial documents and ICH/GCP Section 8 requirements.

Culture & Benefits

• Support for professional growth through skills development and career opportunities.
• Flexibility and work-life balance support.
• Employee ideas and input influence ways of working.
• Opportunity to contribute to medical innovation and clinical research that improves patient lives.