Senior Clinical Research Associate

Translational Oncology Research, LLC; Bologna; In loco; EUR 55.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance plan

Paid annual leave

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 the Monitoring Resources team. This home-based role in Italy requires extensive oncology trial monitoring experience and strong ICH-GCP knowledge.

You will conduct site visits, ensure regulatory compliance, and mentor junior CRAs while supporting data validation and budget activities. Travel up to 60% is expected, with English fluency, a science degree, and experience with CTMS systems.

Competenze

• Bachelor’s degree in science required.
• Fluent in English (read/write/speak).
• Minimum 5 years CRA experience with oncology trials.
• 2+ years of monitoring oncology trials.

Mansioni

• Conduct site visits (pre-study, initiation, monitoring, termination).
• Ensure adherence to FDA, ICH-GCP and local regulations.
• Complete regulatory documents and essential documents collection.
• Perform data verification of source documents.
• Ensure FDA/ICH-GCP compliance is maintained.
• Assist with budget negotiations where applicable.
• Mentor junior CRAs on-site as needed.
• Support data validation and query resolution.

Conoscenze

Oncology trial monitoring

Senior CRA experience

Early-phase trials

English fluent

Medical terminology

ICH-GCP knowledge

Clinical systems experience

Travel readiness

Formazione

Bachelor’s degree in science

Strumenti

CTMS / Clinical trial 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 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.

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 (8-10 site visits per month)
• 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.

Prior to applying please review TRIO's Applicant Information Notice

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.

Teamwork

• Passion
• Integrity
• Innovation