Clinical Research Associate

Veeda Lifesciences; Udine; In loco; EUR 30.000 - 40.000; Tempo pieno

Descrizione del lavoro

A global clinical research organization is seeking a Clinical Research Associate based in Italy. This full-time position involves ensuring compliance with clinical trial protocols, monitoring data accuracy, and collaborating with regulatory bodies. Candidates should have a Bachelor's or Master's degree in Health Sciences, CRA certification, and proficiency in English and Italian. Competitive remuneration package offered.

Servizi

Competitive remuneration package

Competenze

• 6-12 months of CRA work experience.
• Attendance at an ICH GCP training course is desirable.
• Ability to handle stressful situations and manage multiple issues.

Mansioni

• Ensure compliance with protocols and legislation.
• Conduct pre-study visits to assess investigational sites.
• Collaborate with Regulatory Affairs for submissions and approvals.
• Maintain and update Clinical Trial Files.
• Monitor clinical trial conduct and data accuracy.

Conoscenze

Proficiency in English

Proficiency in Italian

Good computer skills

Effective communication skills

Organizational skills

Ability to work independently

Formazione

Bachelor’s or Master’s degree in Health Sciences

Certified 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 approved protocols, 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. A key responsibility is to safeguard subjects' rights and ensure the accuracy, completeness, and verifiability of collected clinical data 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, guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate investigational sites' resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for clinical submissions, contracts, and study approvals.
• Explain study purposes and procedures to investigators, and provide training and support for trial conduct.
• Maintain and update Clinical Trial Files, ensuring proper collection of documents.
• Manage study medication supplies, verify drug accountability, and oversee safe shipment, storage, and disposal.
• Monitor clinical trial conduct, including site visits to verify protocol adherence, data accuracy, and informed consent procedures.
• Ensure timely reporting of safety information and proper drug accountability.
• Document monitoring activities and communicate findings to investigators and the study team.
• Participate in study meetings, provide feedback, and prepare for audits or inspections.
• Support site feasibility assessments, site selection, and patient recruitment strategies.
• Assist in financial management related to investigator payments.
• Manage subject enrollment and data quality, ensuring adherence to operational plans.
• Participate in departmental planning, SOP development, and team mentoring.

Job Requirements :

• Bachelor’s and/or master’s degree, preferably in Health Sciences.
• Certified CRA.
• 6-12 months of CRA work experience.
• Proficiency in English and Italian (oral and written).
• Desirable: Attendance at an ICH GCP training course.
• Good computer, communication, and organizational skills.
• Ability to work independently and as part of a team.
• Effective communication skills, diplomatic and clear.
• Ability to handle stressful situations, flexible with timelines.
• Capacity to manage multiple issues simultaneously.
• Adherence to SOPs, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

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

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