Conduct and oversee site monitoring visits for Phase II/III interventional trials to ensure protocol, GCP, regulatory, and SOP compliance. Manage site initiation, routine monitoring, and closeout; ensure patient safety and data integrity; report and follow up on SAEs; support site feasibility and investigator engagement; maintain documentation and communicate with sites and project teams; travel within Ireland as needed.
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.
- 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.
- 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.
- 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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