Clinical Research Associate 2

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h43jp

Responsibilities

Provide strategic oversight and management of clinical trial sites

Ensure protocol compliance, data integrity, and the protection of patient safety and rights

Drive study quality and performance through risk-based monitoring and proactive risk management

Collaborate with site staff and cross-functional teams to ensure the successful execution of trials

Act as a Site Manager and build trusted partnerships with investigators and site staff

Conduct on-site and remote visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements

Drive the implementation of Risk-Based Quality Management (RBQM) principles

Oversee site performance, recruitment progress, retention and data collection

Manage IMP, study supplies, essential documents and the Investigator Trial Master File





Requirements A bachelor's degree in Life Sciences (preferably Biotechnology, Pharmacy, Chemistry, Biology or CTF)

A minimum of 3 years of clinical trial monitoring experience within the pharmaceutical industry or a CRO

Proven independence in monitoring activities and strong expertise in applying ICH-GCP E6(R3), clinical trial methodology, regulatory requirements, and SOPs

Valid GCP certification required

Solid working knowledge of electronic clinical trial systems, including CTMS, EDC, IWRS and eTMF

Demonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7h43jp