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Clinical Research Associate Contractor (Redmond, WA)

Kelly Services


Location:
Redmond, WA 98073
Date:
08/29/2018
2018-08-292018-10-19
Kelly Services
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Job Details

Kelly Scientific Resources is looking for an experienced **Clinical Research Associate (CRA)** to provide clinical expertise in the support of the design, development, manufacturing and clinical application of Advanced Life Support and Basic Life Support products and accessories. This is an excellent opportunity to land a **one-year contract** with a Fortune 500 biotechnology firm who's aim is to develop the most innovative state of the art medical and surgical equipment.



MAJOR DUTIES/RESPONSIBILITIES:




+ Provide input to, project plans, pre-IDE and 510 k and PMA applications by describing user needs, user characteristics, intended use and clinical application of products; develop operator product performance needs and usability goals; advocate the safety of devices for the operator and the patient.

+ Participate in the development of safety risk analysis; identify system hazards, hazard severity and develop and validate mitigations; develop operator error hazard analysis.

+ Develop User Needs Document as a basis for Design Validation.

+ Determine whether product requirements specification and user interface design and design documents adequately reflect user needs and usability goals.

+ Plan, develop and conduct the design validation process, including usability protocols to demonstrate understanding of labeling or intuitiveness of product design.

+ Interface with customers for the development of use scenarios and user needs; establish customer contacts for clinical use questions and as usability contacts.

+ Review product related complaints related to potential adverse events or device malfunctions to determine whether or not the device use contributed to harm.

+ Analyze data reports and summarize results pertinent to product design and usability.

+ Plan and facilitate creation of operating instructions and evaluate accuracy and adequacy.

+ Plan and develop protocols for minimal risk Clinical Studies; work as clinical liaison between Institutional Review Board and internal Regulatory staff to execute procedures and conduct clinical study.

+ In collaboration with Product Managers and Clinical Marketing, assist in the development of customer, sales and service training materials.

+ Perform other related duties as assigned.



BASIC QUALIFICATIONS:




+ Bachelor s degree in Nursing or related field 5 years critical care and/or emergency experience.

+ AHA ACLS current or prior provider status required and recommended to be maintained.

+ Current RN license; EMT Paramedic or Flight Nurse preferred/desired.

+ Excellent organizational, interpersonal, negotiation and analytical skills.

+ Excellent verbal communication skills.





_Apply Today!_






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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