Senior Clinical Research Associate

TRIO - Translational Research in Oncology; Bologna; Remoto; EUR 55.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Paid annual leave

Health insurance

Flexible hours

Luggage allowance

Phone allowance

Descrizione del lavoro

TRIO (Translational Research in Oncology) is seeking a Senior Clinical Research Associate to join our Monitoring Resources team. The role is home-based in Italy, reporting to a CRA Line Manager, with responsibilities spanning site visits, regulatory compliance, data verification, and mentoring junior CRAs.

The candidate should have 5+ years CRA experience, 2+ years in oncology monitoring, fluent English, and a science-related bachelor’s degree.

Competenze

• Minimum 2 years of oncology trial monitoring experience.
• Minimum 5 years of CRA experience.
• Experience monitoring early-phase trials.
• Read, write and speak fluent English.
• Completion of a science-related Bachelor’s degree.
• Strong ICH-GCP 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.

Mansioni

• Conduct site visits: pre-study, initiation, monitoring, and termination.
• Confirm adherence to FDA, ICH-GCP and local regulations.
• Ensure completion/collection of regulatory documents.
• Perform data source verification.
• Ensure compliance with FDA/ICH-GCP guidelines.
• Participate in budget negotiation and follow-up where applicable.
• Assist with data validation and query resolution.
• Mentor junior team members as required.

Conoscenze

Oncology monitoring

CRA experience

Early-phase monitoring

English fluency

Science degree

ICH-GCP knowledge

Clinical trial systems

Travel willingness

Mentoring juniors

Formazione

Science-related Bachelor’s degree

Strumenti

Clinical Trial Management System (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 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;
• 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
• 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.