Clinical Research Associate

Veeda Lifesciences; Pavia; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A global clinical research organization is seeking a Clinical Research Associate (CRA) based in Italy. This full-time position involves ensuring compliance with clinical trial protocols, managing investigational site activities, and fostering relationships with study personnel. Candidates should possess a degree in Health Sciences, have CRA certification, and speak fluent English and Italian. The role offers a competitive remuneration package and a supportive environment for professional growth.

Servizi

Competitive remuneration package

Multidisciplinary team of scientists and healthcare professionals

Competenze

• 6-12 months of CRA work experience required.
• Attendance at an ICH GCP training course is desirable.

Mansioni

• Ensure compliance with protocols and regulations.
• Conduct pre-study visits to evaluate investigational sites.
• Maintain and update clinical trial documentation.
• Manage study medication supplies and drug accountability.
• Coordinate submissions to regulatory authorities.
• Train Investigators in trial conduct.

Conoscenze

Fluent in English

Fluent in Italian

Good computer skills

Strong organizational skills

Effective communication skills

Ability to handle stressful situations

Formazione

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

Certification as Clinical Research Associate (CRA)

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 that the conduct of clinical trials at selected investigational sites complies with the approved protocol, ICH GCP guidelines, SOPs, and applicable laws and regulations. The CRA acts as the primary communication link between the Sponsor, Investigators, and study personnel, maintaining successful working relationships. The key responsibility is to protect subjects' rights and ensure that collected data are accurate, complete, and verifiable from source documents.

Main responsibilities :

• Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP, local and international legislation, including data protection laws.
• Report deviations from protocols or regulations to the Line Manager and relevant roles.
• Conduct pre-study visits to evaluate investigational sites' resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts.
• Explain study purposes and procedures to Investigators; train and assist them in trial conduct.
• Maintain and update clinical trial documentation and ensure proper collection of essential documents.
• Manage study medication supplies, verify drug accountability, and oversee safe shipment, storage, and disposal.
• Perform monitoring visits to ensure Investigator compliance, verify data accuracy, and confirm informed consent is obtained.
• Ensure proper reporting of safety information and AE/SAE training for Investigators.
• Coordinate submissions to IEC/IRB and regulatory authorities.
• Manage drug accountability and proper dispensing.
• Document monitoring activities and communicate with Investigators.
• Participate in study meetings, provide feedback, and prepare for audits or inspections.
• Assist in site feasibility, screening, and selection.
• Support financial aspects, including Investigator payments.
• Manage subject enrollment and data quality.
• Evaluate patient recruitment and operational procedures.
• Close study sites after trial completion.
• Participate in departmental planning and SOP development.
• Provide coaching and mentorship to new or less experienced CRAs.

Job Requirements :

• Bachelor’s and/or Master’s degree, preferably in Health Sciences.
• Certified CRA.
• 6-12 months of CRA work experience.
• Fluent in English and Italian (oral and written).
• Attendance at an ICH GCP training course (desirable).
• Good computer and communication skills.
• Strong organizational skills and ability to work independently and in teams.
• Effective communication skills, diplomatic and clear.
• Ability to handle stressful situations, manage multiple issues, and work within SOPs and regulations.
• Willingness to travel frequently, including international trips, evenings, and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals at the forefront of clinical research in a friendly environment. We offer a competitive remuneration package.

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