Role: Clinical Research Associate (12+ months' monitoring experience required)
Location: must be based in Ireland
Fully sponsor dedicated
As a CRA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
As Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in oncology, general medicine, and eye care. You will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration, and performance.
Your responsibilities include, but are not limited to:
1. Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommend sites to participate in clinical trials and ensure successful collaboration, meeting ICON's expectations on milestones and deliveries.
2. Manage assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and client procedures. Perform Site Initiation Visits, ensuring site personnel is fully trained on all trial-related aspects.
3. Conduct continuous monitoring activities (onsite and remote) to ensure compliance with protocols, GCP, and regulations, securing data integrity and patient safety.
4. Ensure that study milestones for responsible sites are met as planned. Perform Site Closeout activities per SOPs and applicable regulations.
5. Document monitoring activities appropriately following ICON standards. Collaborate with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans as needed.
6. Monitor studies as per current legislations, ICH/GCP, and client standards, ensuring timely delivery of high-quality data.
7. Collaborate with internal stakeholders and site personnel to manage data query resolution processes.
8. Negotiate investigator remuneration and prepare financial contracts between ICON and investigational sites.
You will need the following:
* Right to work in Ireland and Northern Ireland.
* Up to 2 years of pharmaceutical industry experience or other relevant experience (NHS or Academic).
* Good knowledge of the drug development process, specifically clinical trial/research.
* Knowledge of international standards (GCP/ICH, FDA, EMEA).
* 12+ months' monitoring experience required.
Important for the role:
* Ability to travel domestically (and possibly internationally) as needed.
* A minimum of 50% overnight travel may be required.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
* Various annual leave entitlements.
* A range of health insurance offerings.
* Competitive retirement planning offerings.
* Global Employee Assistance Programme, offering 24-hour access to support.
* Life assurance.
* Flexible country-specific optional benefits.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates.
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