Clinical Research Associate - Medical Devices

As a Clinical Reserach Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
• Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
• Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
• Attend all required meetings and provide updates to team.
• Support EDC user acceptance testing and training as applicable.
• Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.

You are:

• Bachelor or Masters in Science or Healthcare discipline.
• Approximately 2 years related experience in clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry).
• At least 2 years of experience as a Clinical Research Associate monitoring clinical studies
• Experience in using EDC and CTMS systems is desirable.
• Experience with direct line management of staff including hiring, training, oversight and mentoring.
• Good command of written and spoken English language.
• Excellent verbal and written communications skills.
• A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.
• Ability to work very accurate and thorough.
• Excellent record-keeping skills; good documentation practice.
• Flexibility in work hours and readiness to travel.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

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.

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.

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