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
We are currently seeking a Senior Clinical Research Associate to join our diverse and dynamic FSP team in Romania. As a Senior Clinical Research Associate at ICON Plc, you will work as a sponsor dedicated CRA and play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards.
What You Will Be Doing:
Monitoring clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
Assessment and qualification of potential investigative sites, initiating clinical trials at investigative sites, instructing site personnel on the proper conduct of clinical trials, and closing clinical trials at investigative sites.
Review and verifying the accuracy of clinical trial data collected, either on site or remotely.
Performing source document verification and query resolution.
Assessment of investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
Verification of SAE reporting according to trial specifications and ICH GCP guidelines.
Ensuring that all required training is completed and documented.
Facilitating audits and audit resolution.
Your Profile:
Advanced degree in a relevant field such as life sciences, nursing, or medicine.
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements.
4 or more years of clinical monitoring experience required.
Experience in monitoring complex trials preferred.
Participation in departmental initiatives preferred.
Read, write, and speak fluent English; fluent in host country language required.
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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.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.
Are you a current ICON Employee? Please click here to apply
Top Skills
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
