Clinical Study Specialist 2

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.

Supports the site team with administrative tasks needed for initiation, conduction and closure of the studies at research
site, as described below, but not limited too and any other tasks administrative in nature, and that are properly
delegated:
• Support the submission of the protocol and other documents to the ethics committee (EC) and the development of
files and binders
• Support sites with tools and trackers that support flow of regulatory and study documents or materials, as needed.
• Transcription of source document datapoints into EDC/CRF including query response according to the timelines and
which can be clearly accessed in source documents
• 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 to CRA reviews, accommodate meetings with site staff, etc.
• Manage meetings and also prepare meeting minutes, as needed.
• Escalate issues to the applicable management team.
• Track study specific training.
• May support and communicate with outside vendors for the study.
• Take effective action to prevent and to recover errors in the responsible tasks.
• Assist with the completion of final queries and eCRFs in order to achieve DBL in the expected timeline.
• Assist in the resolution of any open action items at the site.
• Support with administrative study close-out activities.
• Can demonstrate good computer skills.

• Knowledge of GCP/ICH
• Good written and verbal communication skills. Should be able to adapt communication style to suit different audiences.
• Read, write and speak English, desirable.
• Skills in IT systems, platforms, creations of spreadsheets, tables and other applicable tools as needed.
• Work is consistently high quality, selfmotivating, ethic and commitment.
• Maintain a good relationship with site
• Associate’s degree in a science related field,
• preferred 0-2 years of clinical research experience
• High English level

Benefits of Working in ICON:

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.

At 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.

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, 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.

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