Clinical Research Associate

Schneider Electric; Remoto; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization is seeking an experienced Clinical Research Associate to join its Monitoring Resources team. This role, based in Italy, focuses on oncology research, requiring a minimum of 2 years of monitoring experience. Responsibilities include conducting site visits, ensuring compliance with regulations, and mentoring junior staff. Ideal candidates will have a relevant Bachelor's degree and knowledge of ICH-GCP guidelines. The company offers a competitive benefits package including health insurance and paid leave.

Servizi

Paid annual leave

Health insurance plan

Competenze

• Minimum of 2 years of monitoring experience in oncology trials.
• Experience in monitoring early-phase trials.
• Ability to travel up to 60% on average.

Mansioni

• Conduct site visits, including pre-study, initiation, monitoring, and termination.
• Confirm adherence to FDA, ICH-GCP and local regulations.
• Ensure completion and collection of regulatory documents.

Conoscenze

Monitoring experience

Knowledge of medical terminology

Clinical trial information systems

Strong ICH-GCP knowledge

Formazione

Science-related Bachelor's degree

Descrizione del lavoro

If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you!

Translational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Clinical Research Associate to join our Monitoring Resources team. Reporting to a CRA Line Manager, this position will be home-based in Italy.

Responsibilities

• Conducting site visits, including pre-study, initiation, monitoring, and termination;
• Confirming adherence to all FDA, ICH-GCP and local regulations;
• Ensuring the completion and collection of regulatory documents;
• Performing data verification of source documents;
• Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
• Participating in budget negotiation and follow-up where applicable;
• Assisting with data validation and query resolution;
• Mentoring junior team members as required.

Qualifications

• A minimum of 2 years of monitoring experience in oncology trials
• Experience in monitoring early-phase trials
• Completion of a science-related Bachelor’s degree
• Excellent knowledge of medical terminology and clinical monitoring process
• Strong ICH-GCPs knowledge
• Experience with clinical trial information systems
• Ability to travel up to 60% on average

What TRIO Can Offer You

• Paid annual leave
• Health insurance plan

Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.

If you are interested, please submit your resume in English. We thank all candidates for their interest; only those selected for an interview will be contacted.