Clinical Research Associate - Freelance

About TRIO

TRIO (Translational Research in Oncology) is a global academic clinical research organization focused on advancing translational cancer research within clinical trials. The organization is dedicated to delivering cutting-edge cancer treatments to patients today.

Role Overview

TRIO seeks a Clinical Research Associate to join their Monitoring Resource team. This is a full-time freelance position, performed remotely within Ireland, reporting directly to the CRA Line Manager.

Key Responsibilities

• Verify source documents rigorously to ensure data accuracy.
• Conduct various site visits including pre-study assessments, site initiation, monitoring visits, and study termination visits.
• Ensure strict compliance with FDA regulations, ICH-GCP guidelines, and applicable local laws.
• Support implementation and adherence to FDA and ICH-GCP standards throughout trials.
• Engage in budget negotiation processes and subsequent follow-up where relevant.
• Assist in data validation efforts and resolve data queries promptly.
• Provide mentorship and guidance to junior team members when requested.
• Oversee completion and collection of essential regulatory documentation.

Qualifications and Experience

• At least 2 years of experience monitoring oncology clinical trials.
• Monitoring experience in early-phase oncology studies is highly valued.
• Bachelor’s degree in a science-related field.
• Strong understanding of medical terminology and clinical monitoring procedures.
• Comprehensive knowledge of ICH-GCP guidelines and standards.
• Familiarity with clinical trial information management systems.
• Willingness and ability to travel up to 60% on average.
• Legal authorization to work in Ireland is mandatory.