Set Up Specialist

Set Up Specialist - Portland OR- hybrid

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

Set Up Specialist – Portland, OR- Hybrid

The role:
Selected to coordinate clinical trial start-up activities and serve as primary contact for investigators and research coordinators in corporate sponsored human clinical trials.
• Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Serve as the primary liaison with the sponsor during the setup phase of the study.
• Own the Sponsor Online Laboratory Requirements (SOLAR) completion process. Ensure all information and specifications are captured in SOLAR and are accurate by considering the study protocol, sponsor requests, ICON Laboratory standards, and requests/recommendations from internal operational groups.
• Working independently, coordinate and manage the completion of the SOLAR 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).
• Must have an in-depth knowledge of ICON 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 SOLAR 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 SOLAR template, Laboratory Manual template, Requisition template, and other items, as necessary.
• Serve as a resource in respect to the overall setup process for internal parties such as Project Management and the Laboratory.
What you need:

The successful applicant will have a background of working on clinical trials. This will be in a laboratory, clinical trials, or project management within the pharmaceutical industry.

Database experience specifically with LIMS is an added advantage or any additional databases
Most of the team hold a BA or BSc in Life Sciences or a related area of expertise.
Our team members have working knowledge of MS Word, Excel, and PowerPoint.
Possess the ability to multitask, remain composed and even keeled in stressful situations, and perform effectively despite shifting priorities, workload and external pressures.
If you have 2+ years of working in this environment we would love to hear from you
 

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

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.

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