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Set Up Specialist

JR072655

About the role

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Set Up Specialist role within ICON:
Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.
  • Serve as the primary liaison with the sponsor during the setup phase of the study
  • Own the Client Laboratory Worksheet (CLW) completion process. Ensure all information and specifications are captured in the Client Laboratory Worksheet (CLW) and are accurate by taking into account the study protocol, sponsor requests, ICON Laboratory standards, and requests/recommendations from internal operational groups.
  • Working independently, coordinate and manage the completion of the Client Laboratory Worksheet (CLW) and communication of information as required to the other departments within ICON Laboratories (and ICON Clinical CRO if appropriate).
  • Serve as the subject matter expert for the Sponsor in guiding them through a successful setup process by drawing on past experiences and standards. Highlight any risks associated with the study to the sponsor and internal parties including participating in internal risk assessment and other operational meetings as necessary.
  • Communicate major decisions or timeline changes during setup with the Laboratory Project Manager and other laboratory staff as necessary (and ICON Clinical CRO if appropriate). Independently manage the laboratory setup timeline.
  • Must have an in-depth knowledge of Laboratory database and how amendments to the database will affect different operational areas of laboratory and be able to efficiently anticipate and communicate these changes to all internal and external parties including sponsor clinical and data management teams.
  • Present solutions and establish best practices for laboratory setups for new and complex protocol requirements.
  • Lead projects in respect to setup process improvement and serve as a member for other projects utilizing subject matter expertise.
  • Contribute toward the maintenance of setup related documents such as the CLW template, Laboratory Manual template, Requisition template, and other items as necessary.
  • Serve as a resource in respect to the overall laboratory setup process for internal parties such as Project Management and the Laboratory.
Benefits of working at ICON:
We provide a Set Up Specialist with the resources to be successful and visibility by having them provide input and recommendation to upper management on the study start up submission process and how to better the work process. In addition, we offer excellent health, dental, vision and life insurance coverage; 401(K) with company match; competitive pay; generous time off; and bonus incentives.
To succeed you will need:
A Bachelor's Degree or local equivalent. Minimum of 3 years experience in MS Word and Excel.
Why join us?
On-going development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent retirement plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin.
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