CRA (Level II)

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Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office
Job Description

We're looking for a

Clinical Research Associate II (CRA II)

to join our growing Clinical Operations team in

Italy . If you're passionate about clinical research, enjoy building strong site relationships, and want to contribute to studies that make a real difference for patients worldwide, we'd love to hear from you.

What You'll Do

As a CRA II, you'll be responsible for monitoring clinical trial sites and ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, applicable regulations, and company SOPs.
Your responsibilities will include:
Conducting on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach.
Ensuring subject safety, data integrity, and protocol compliance.
Performing Source Data Verification (SDV), Source Data Review (SDR),



and CRF review.
Assessing investigational product accountability through inventory and documentation reviews.
Identifying site issues, performing root cause analysis, and implementing corrective and preventive actions (CAPA).
Preparing high-quality monitoring reports and ensuring timely follow-up of action items.
Supporting site initiation, routine monitoring, and close-out visits.
Reviewing essential documents to ensure compliance with ICH-GCP and regulatory requirements.
Maintaining study documentation and updating clinical trial management systems (CTMS).
Building collaborative relationships with investigators, site staff, sponsors, and cross-functional project teams.
Supporting audit and inspection readiness throughout the study lifecycle.
Participating in investigator meetings and contributing to process improvement initiatives.
Completing administrative activities, including expense reports and t

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7j2jjg