Clinical Research Associate

Veeda Lifesciences; Trieste/Trst; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global CRO is seeking a Clinical Research Associate (CRA) in Italy to ensure compliance in clinical trials and maintain communication with investigators. The ideal candidate will have a Bachelor's or Master's in Health Sciences, CRA certification, and fluency in English and Italian. This full-time role includes responsibilities such as conducting site visits, managing safety reporting, and providing mentorship to junior CRAs. A competitive remuneration package is offered.

Servizi

Competitive remuneration package

Competenze

• 6-12 months of CRA work experience.
• Certified CRA.
• Proficient in computer skills and communication.

Mansioni

• Ensure compliance with quality and information security standards.
• Conduct pre-study site visits to assess feasibility.
• Verify adequate study medication supply and proper drug accountability.

Conoscenze

Fluent in English and Italian

Strong organizational skills

Effective communication

Formazione

Bachelor’s and/or Master’s degree in Health Sciences

Descrizione del lavoro

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job Overview:

The CRA is responsible for ensuring the conduct of clinical trials at selected investigational sites complies with approved protocols, ICH GCP guidelines, SOPs, and applicable laws. They serve as the primary communication link between the Sponsor, Investigators, and study personnel, maintaining successful relationships. A key responsibility is to ensure subjects' rights are protected and all clinical data are accurate, complete, and source-verifiable.

Main Responsibilities:

• Ensure compliance with company quality and information security standards, ICH GCP, local and international legislation, including data protection laws.
• Report deviations from protocols, guidelines, or legislation to the Line Manager per SOPs.
• Conduct pre-study site visits to assess feasibility and resources.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions, contracts, and study approvals.
• Explain study procedures to Investigators, provide training, and assist in trial conduct.
• Maintain and update clinical trial files, ensuring proper documentation.
• Verify adequate study medication supply, proper drug accountability, and safe shipment and storage.
• Perform monitoring visits to ensure investigator compliance, verify data accuracy, and confirm informed consent procedures.
• Manage safety reporting and ensure investigator training on adverse event reporting.
• Prepare reports on monitoring activities and participate in study meetings.
• Assist with audit and inspection preparations, working with QA teams.
• Support site feasibility, patient recruitment, and data quality management.
• Participate in SOP development and departmental planning.
• Provide coaching and mentorship to less experienced CRAs.

Job Requirements:

• Bachelor’s and/or Master’s degree in Health Sciences preferred.
• Certified CRA.
• 6-12 months of CRA work experience.
• Fluent in English and Italian (oral and written).
• Experience with ICH GCP training (desirable).
• Proficient in computer skills and communication.
• Strong organizational and independent working skills.
• Effective communication with site personnel and ability to handle stressful situations.
• Willingness to travel internationally and domestically, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a friendly environment. We offer a competitive remuneration package.

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