Senior Clinical Research Associate

Translational Research in Oncology; 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

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

You will conduct site visits, ensure regulatory compliance, and mentor junior CRAs. Fluency in English and a science-related Bachelor's degree are required.

We offer a competitive salary, paid leave, health insurance, flexible hours, and travel up to 60% for 8–10 site visits per month.

Competenze

• Minimum 2 years of monitoring experience in oncology trials.
• Minimum 5 years of CRA experience with early-phase trials.
• Fluent reading, writing and speaking of English.
• Willingness to travel up to 60% (8-10 site visits per month).

Mansioni

• Conduct site visits at pre-study, initiation, monitoring and termination.
• Ensure adherence to FDA, ICH-GCP and local regulations.
• Collect and verify regulatory documents and source data.
• Maintain compliance with FDA and ICH-GCP guidelines.
• Participate in budget negotiation and follow-up when applicable.
• Support data validation and resolve queries.
• Mentor and train junior CRAs on-site.

Conoscenze

Oncology monitoring

Mentoring juniors

Fluent English

Travel readiness

Formazione

Science-related Bachelor's degree

Strumenti

CTMS

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 Associateto 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;
• 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:

• 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.

Teamwork Passion Integrity Innovation