Sr. Specialist, Laboratory - Clinical Studies (RACA)

Find a Better Way...

...to use your skills and experience.

This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

...to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

...to build a promising future.

We currently have a great opportunity available for a Sr. Specialist, Laboratory - Clinical Studies (RACA). The Laboratory Specialist in this role will work with the Regulatory and Clinical Affairs (RACA) Laboratory Manager to support in-house studies. This Associate will have a thorough understanding and be able to perform the IVD sub-studies required in FDA submissions.

Essential Duties and Responsibilities:

1. Perform testing on prototype, investigational use, and on-market clinical laboratory instruments, software, reagents, and controls manufactured by Sysmex America Incorporated (SAI) and similar instruments and products. Adhere to established procedures, study-specific protocols, and timelines. Perform data entry as needed.
2. Evaluate the Investigational Use Only (IUO) instruments according to Instructions for Use / package inserts. Learn to operate comparator and/or screening devices and confirmatory tests.
3. Perform routine laboratory functions such as; running QC (would also be responsible for monitoring the QC process in RACA Laboratory), performing and properly documenting preventative maintenance, monitoring laboratory supplies (consumables, reagents, controls, chemicals, etc.), and ordering supplies as needed.
4. Have the ability to evaluate results, recognize problems, and initiate troubleshooting if necessary. Become an instrument and/or troubleshooting resource both internally and externally (clinical sites).
5. Have a thorough understanding of and be able to perform various sub-studies required in FDA submissions such as; linearity, repeatability, reproducibility, carry-over, and method comparisons. Have the ability and understand how to contrive samples to meet study requirements.
6. Ability to travel (if needed) to Clinical Study sites and conduct the technical device training of Clinical
Study personnel.
7. Support Clinical Affairs with the shipment of analyzers and reagents/supplies from the RACA Lab with transportation and TPMs.
8. Ability to create and maintain laboratory and study documents.
9. Strong organizational skills and high attention to detail.
10. Follow all Sysmex policies for safety, environment, and infection control.

Percentage of Travel: 5-10%

Physical Demands: Moderate physical activity. Routine handling of objects 21 to 50 pounds; continuous (at least 80% of time) walking or inspections, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.

Bachelor's degree and 7+years Laboratory experience required, including experience in the Armed Forces. Bachelor's degree with a specialization in Medical Technology preferred.

• ASCP certification or clinical research preferred

• Ability to perform CBC differentials, detail-oriented.

• Excellent command/highly proficient in spoken and written English

• Proficient in Microsoft Office (Word, Excel, Power Point).

• Clinical Applications or Training experience is a plus.

• Phlebotomy skills are a plus.

This job requires satisfaction of the credentialing requirements of Sysmex's customers, including hospitals and other healthcare facilities, which generally includes proof of current vaccinations for measles, mumps, rubella, varicella (chicken pox), and COVID-19. Further, Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status to the extent permitted by applicable law. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job including working at customer locations.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.