Senior CRA

at  Icon plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.
You will be partnering with one of our global pharmaceutical clients; a company that is advancing the development of new medicines, biologic therapies and vaccines for many of the world’s most challenging diseases including cancer, cardio-metabolic diseases, Alzheimer’s and infectious diseases. Be ready to work in a solid partnership and an environment driven by innovation and continuous improvement.

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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles

• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
• Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Participates in audit preparation and follow-up activities as needed.
• May serve as preceptor, providing training to less experienced clinical team members.
• May be assigned clinical tasks where advanced negotiating skills are required.

You are:

• Bachelor’s degree in a health, life sciences or other relevant field of study.
• Previous experience supporting clinical trials including 4Y of direct site management (monitoring) experience.
• Previous experience in oncology is a plus.
• Travel is required.
• All employees must read, write and speak fluent English and host country language.