Senior Oncology CRA - Home-Based in Italy, Mentorship

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

You will conduct site visits, ensure FDA/ICH-GCP compliance, manage regulatory documents, and mentor junior CRAs. The ideal candidate has 5+ years CRA experience, 2+ years oncology monitoring, and fluent English.

Competenze

• Minimum 5 years of CRA experience
• 2+ years monitoring in oncology trials
• Fluent English, both written and spoken
• Completion of a science-related Bachelor’s degree
• Strong knowledge of ICH-GCPs
• Willingness to travel up to 60%
• Ability to mentor junior CRAs on-site

Mansioni

• Conduct site visits including pre-study, initiation, monitoring and termination
• Ensure adherence to FDA, ICH-GCP and local regulations
• Complete and collect regulatory documents
• Perform data verification of source documents
• Ensure compliance with FDA and ICH-GCP guidelines
• Participate in budget negotiations and follow-up
• Assist with data validation and query resolution
• Mentor junior team members

Conoscenze

Monitoring experience

Oncology trials

English fluency

Bachelor’s degree in science

ICH-GCP knowledge

Clinical trial systems

Travel readiness

Formazione

Bachelor’s degree in a science

Strumenti

Clinical trial information systems

Descrizione del lavoro

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

You will conduct site visits, ensure FDA/ICH-GCP compliance, manage regulatory documents, and mentor junior CRAs. The ideal candidate has 5+ years CRA experience, 2+ years oncology monitoring, and fluent English.