Senior Clinical Research Associate

triotranslationalresearchinoncology; Bologna; Remoto; 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

TR translational Research in Oncology (TRIO) is seeking a Senior Clinical Research Associate to join the Monitoring Resources team. The role is home-based in Italy, reporting to a CRA Line Manager, with responsibilities including site visits, regulatory compliance, data verification, and budget support.

Requirements include 5+ years CRA experience, 2+ years in oncology monitoring, fluent English, and a science-related bachelor’s degree. Travel up to 60% and mentoring duties are expected.

Competenze

• Bachelor’s degree in a science-related field.
• Minimum 2 years monitoring in oncology trials and 5 years CRA experience.
• Fluent written and spoken English; ability to travel up to 60%.
• Strong knowledge of ICH-GCP and FDA regulations; experience with trial systems.

Mansioni

• Perform site visits (pre-study, initiation, monitoring, termination).
• Ensure adherence to FDA, ICH-GCP and local regulations.
• Collect regulatory documents and perform data verification.
• Support budget negotiations and sponsor queries where applicable.
• Mentor junior CRAs on-site and train team members.

Conoscenze

Oncology monitoring

Site visits

ICH-GCP knowledge

English fluency

Science-related Bachelor's degree

Medical terminology

Clinical trial systems

Mentoring junior CRAs

Travel up to 60%

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 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.

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