Senior Clinical Research Associate

Translational Research in Oncology; Roma; In loco; EUR 55.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Paid annual leave

Health insurance plan

Flexible working hours

Luggage allowance

Mobile phone allowance

Descrizione del lavoro

Translational Research in Oncology (TRIO) is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. This home-based role in Italy reports to a CRA Line Manager and is a full-time position.

You will conduct site visits, ensure regulatory compliance, perform data verification, and mentor junior CRAs. Fluent English and a science-related Bachelor’s degree are required, with up to 60% travel.

Competenze

• Minimum 2 years of monitoring experience in oncology trials.
• Minimum 5 years of CRA experience.
• Experience with early-phase trials and ICH-GCP knowledge.

Mansioni

• Conduct site visits (pre-study, initiation, monitoring, termination).
• Ensure adherence to FDA, ICH-GCP and local regulations.
• Complete and collect regulatory documents; perform data verification.
• Ensure FDA/ICH-GCP guidelines are implemented and followed.
• Participate in budget negotiation and follow-up where applicable.
• Mentor and train junior CRAs on-site.

Conoscenze

Fluent English

Formazione

Science-related Bachelor's degree

Strumenti

Clinical trial information systems

Descrizione del lavoro

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 organizationdedicated 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;
• Confirmingadherence 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:

• 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.

To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI.

To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI-generated responses during interviews or assessments. We want the opportunity to get to know you and your experience.