Senior Oncology CRA — Remote (Italy) | Flexible Hours

TRIO - Translational Research in Oncology; Bologna; Remoto; EUR 55.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid annual leave

Health insurance

Flexible hours

Luggage allowance

Phone allowance

Descrizione del lavoro

TRIO (Translational Research in Oncology) is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. The role is home-based in Italy, reporting to a CRA Line Manager, with responsibilities spanning site visits, regulatory compliance, data verification, and mentoring junior CRAs.

The candidate should have 5+ years CRA experience, 2+ years in oncology monitoring, fluent English, and a science-related bachelor’s degree.

Competenze

• Minimum 2 years of oncology trial monitoring experience.
• Minimum 5 years of CRA experience.
• Experience monitoring early-phase trials.
• Read, write and speak fluent English.
• Completion of a science-related Bachelor’s degree.
• Strong ICH-GCP knowledge.
• Experience with clinical trial information systems.
• Ability to travel up to 60% on average.
• Ability to mentor and train new/junior CRAs on-site in a positive and effective manner.

Mansioni

• Conduct site visits: pre-study, initiation, monitoring, and termination.
• Confirm adherence to FDA, ICH-GCP and local regulations.
• Ensure completion/collection of regulatory documents.
• Perform data source verification.
• Ensure compliance with FDA/ICH-GCP guidelines.
• Participate in budget negotiation and follow-up where applicable.
• Assist with data validation and query resolution.
• Mentor junior team members as required.

Conoscenze

Oncology monitoring

CRA experience

Early-phase monitoring

English fluency

Science degree

ICH-GCP knowledge

Clinical trial systems

Travel willingness

Mentoring juniors

Formazione

Science-related Bachelor’s degree

Strumenti

Clinical Trial Management System (CTMS)

Descrizione del lavoro

TRIO (Translational Research in Oncology) is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. The role is home-based in Italy, reporting to a CRA Line Manager, with responsibilities spanning site visits, regulatory compliance, data verification, and mentoring junior CRAs.

The candidate should have 5+ years CRA experience, 2+ years in oncology monitoring, fluent English, and a science-related bachelor’s degree.