If you are an experienced Senior 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 Senior Clinical Research Associate to join our Monitoring Resources team. Reporting to a CRA Line Manager, this position will be home-based in Italy. This is a full-time position.
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
Minimum 5 years of previous CRA experience
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
What TRIO Can Offer You Competitive salary
Paid annual leave
Health insurance plan
Flexible working hours
Luggage allowance
Mobile phone allowance
Pay Range: 55,000.00 to 65,000.00 Euro - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.

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Senior Clinical Research Associate

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