Senior Clinical Research Associate - Oncology

4w4 weeks ago

TRIO (Translational Research in Oncology)

Milan, IT · Full-time · €55,000 – €65,000

About this role

Translational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. We are looking for an experienced Senior CRA who is passionate about oncology research to join our highly skilled and knowledgeable Monitoring Resources team.

This home-based position in Italy involves conducting site visits including pre-study, initiation, monitoring, and termination. You will confirm adherence to all FDA, ICH-GCP and local regulations while ensuring the completion and collection of regulatory documents.

You will perform data verification of source documents and assist with data validation and query resolution. The role also includes participating in budget negotiation and follow-up where applicable, as well as mentoring junior team members as required.

At TRIO, you will join a passionate team committed to providing cancer treatments of the future to the world of today. This full-time position offers the opportunity to work on cutting-edge oncology trials while contributing to a mission-driven organization.

Requirements

Minimum 5 years of previous CRA experience
A minimum of 2 years of monitoring experience in oncology trials
Experience in monitoring early-phase trials
Read, write and speak fluent English
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
Ability to mentor and train new/junior CRAs on-site in a positive and effective manner

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