Note: The job is a remote job and is open to candidates in USA. TRIO - Translational Research in Oncology is a global academic clinical research organization focused on advancing cancer research. They are seeking a Clinical Research Associate to join their Monitoring Resource team, responsible for conducting site visits, ensuring compliance with regulations, and mentoring junior team members.

Responsibilities

• Performing data verification of source documents
• Conducting site visits, including pre-study, initiation, monitoring, and termination
• Confirming adherence to all FDA, ICH-GCP, and local regulations
• Ensuring implementation and compliance with FDA, and 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
• Ensuring the completion and collection of regulatory documents

Skills

• A minimum of 2 years of monitoring experience in oncology trials
• Experience monitoring in early-phase trials will be valued
• 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
• Must be legally authorized to work in the country

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