Spec 3, Clinical Research

BS / BA / MA in Clinical Laboratory Science or Medical Technology, Biology Life Sciences or health related field required.

REQUIRED ALL CANDIDATES SUBMTTED TO THIS REQ MUST HAVE A VALID LICENSE THAT DATES THE LENGTH OF THE ASSIGNMENT . A COPY OF THE LICENSE WILL BE NEEDED TO BE PRESENTED PRIOR TO INTERVIEW

Title Clinical Lab Specialist

10 panel drug test is required

It is our policy at Client that all Associates and Contract / Consultant employees who work with potentially infectious materials (i.E., blood) have their Hepatitis B vaccination or have been offered one by their employe Please review this with current contractors

We do not need to have the medical records, but need to know the following. Please keep all medical records confidential and in the safety of your company records.

Client requires documentation one of the following :

• Hepatitis B vaccine has been offered and accepted
• Hepatitis B vaccine has been offered and rejected
• Contractor / Consultant has had previously been vaccinated for Hepatitis B and no further action taken
• Contractor / Consultant has had previously been vaccinated for Hepatitis B and wants to have titer testing to ensure antibody status
• Vaccine has not been offered

On Site in Flks 5 days WEEK 8 : 30 TO 5 : 00

Working with Human Blood

This laboratory-based position will provide input to design, evaluation, execution and reporting for safety and efficacy of new or modified in-vitro diagnostic devices, as well as provide innovative ideas cross functionally with other business units. Possess a technical competence and works with human blood in clinical laboratory disciplines such as phlebotomy, chemistry, hematology, coagulation, urinalysis, point of care and capable operation of numerous instrument platforms. Responsible for managing clinical laboratory studies and complaint testing through a variety of clinical testing methods. Knowledge and expertise demonstrating safety and efficacy of new or modified in-vitro diagnostic devices, as well provide innovative ideas outside of the core business. Develop / implement new testing methodologies in collaboration with R&D. Responsible for understanding product design, function and able to apply quality and regulatory standards. Capable of performing Clinical Software Validations (CSV) and all requirements for new instrument validation / qualification as it relates to best practices for the IQ / OQ / PQ in the clinical lab. Utilizes technical / scientific judgment to resolve technical issues. Works with many different disciplines (manufacturing, marketing, quality, regulatory, etc.), materials, products and processes in the development of core clinical laboratory and outside the core clinical laboratory products and services. Possesses a strong commitment to quality and continuous improvement.

PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES :

KNOWLEDGE AND SKILLS :

Proven understanding of clinical laboratory testing, blood collection, Urinalysis, POC and LIS / LIMS systems and an ability to apply knowledge to innovative concepts / projects beyond the core clinical laboratory.

EDUCATION AND EXPERIENCE :