Senior Study Support Assistant

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What you will be doing:

• The Study Support Assistant will support administrative activities at sponsor's sites. 

  Pre-screening and screening phase:

  • Support the submission of the protocol and other documents to the ethics committee (EC) for approval and the development and maintenance of files and binders.

  During trial conduct:

  • Assist with scheduling patient visits.
  • Transcription of source document datapoints into EDC including query response according to the timelines and which can be clearly accessed in source documents.
  • Submission of applicable trial documents to the ethical and regulatory entities.
  • Archive and maintenance of the regulatory folders and binders.
  • On-site and off-site monitoring visit support, such as communication with CRAs for scheduling visits, providing access to site documentation and supplies to CRA reviews, accommodate meetings with site staff, etc.
  • Audit support, as needed.
  • Manage meetings, as needed.

  At closure and follow-up:

  • Support scheduling of follow-up visits.
  • Completion of queries and CRFs in order to achieve DBL in the expected timeline.
  • Support the resolution of any open action item at the site.
  • Support with study close-out visits.

You are:

• Bachelor's degree in a Science related field.
• Experience working with administrative activities in clinical trials.
• Read, write and speak fluent English; fluent in host country language required

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.