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TRIO is looking for a Clinical Research Associate to join our Monitoring Resource team. Reporting to the CRA Line Manager, this position will be a remote full-time freelance position based in Ireland.
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
- 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
Key Skills
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Join TRIO - Translational Research in Oncology and take your career to the next level!
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