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AI Summary
Conduct and oversee study site monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements. Manage all aspects of site activities including initiation, routine monitoring, and closeout while ensuring patient safety and data integrity.
Fortrea is hiring an experienced CRA II to join our client-dedicated team supporting a leading global pharmaceutical company. This is a home-based role in Ireland, with a preference for candidates located in the Dublin area.
Why Join Fortrea?
- Be part of a global, innovative organization driving advancements in clinical research.
- Work in a dedicated partnership with a leading pharmaceutical sponsor.
- Contribute to Phase II and III interventional clinical trials across a range of therapeutic areas.
- Enjoy career growth opportunities, ongoing development, and exposure to high-impact studies.
- Join a collaborative and supportive team that values quality, accountability, and innovation.
Key Responsibilities
- Conduct and oversee study site monitoring visits to ensure compliance with protocols, GCP, regulatory requirements, and company SOPs.
- Manage all aspects of site activities, including site initiation, routine monitoring visits, and closeout visits.
- Ensure patient safety, data integrity, and inspection readiness throughout the study lifecycle.
- Support site feasibility, investigator engagement, and collaboration with study stakeholders.
- Report and follow up on Serious Adverse Events (SAEs) and other safety-related issues as required.
- Maintain accurate documentation and timely communication with sites and project teams.
- Demonstrate a proactive approach to problem-solving and issue resolution.
What We're Looking For
- University/college degree in life sciences or a related healthcare field.
- Previous experience as a Clinical Research Associate or in a comparable clinical research role.
- Experience supporting Phase II and/or Phase III interventional drug studies preferred.
- Experience in Oncology is advantageous.
- Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
- Excellent written and verbal communication skills.
- Strong collaboration and stakeholder management abilities.
- Comfortable working across multiple systems and technologies, including adapting to new and evolving processes and tools.
- Valid driver's license and willingness to travel within Ireland.
Join Fortrea and help bring innovative therapies to patients while advancing your career within a global clinical research organization!
Learn more about our EEO & Accommodations request here.
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