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1+ months

Senior Clinical Research Associate (Remote)

Kelly Services
Raleigh, NC 27608 Work Remotely
**Senior Clinical Research Associate**


Kelly Services is currently seeking a Senior Clinical Research Associate for a long-term engagement with one of our Global Pharmaceutical clients.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Position Summary**


The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to:


+ Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements

+ Validating product performance claims

+ Supplying data for critical Regulatory submissions

+ Defining the functional and clinical utility of investigational products, and

+ Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.


The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.


**Responsibilities**


+ Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout.

+ Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.

+ Interfacing with cross functional staff to support post launch activities.

+ Reviewing cases with investigators to resolve discrepancies.

+ Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures


**Experience and Skills**


+ Excellent oral and written communication skills

+ Excellent planning, organizing, and interpersonal skills

+ Ability to work independently, make sound decisions, and to analyze and solve problems

+ Demonstrated experience in computer skills to include Microsoft Office, and basic templates

+ Medical laboratory experience

+ Up to 2 years of experience in CRA IVD role required


**Education Requirements**


+ Minimum - Bachelor's degree in science or relevant field.

+ Medical technology degree preferred, but not required if R&D background is adequate


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-27 Expires: 2021-12-02

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Senior Clinical Research Associate (Remote)

Kelly Services
Raleigh, NC 27608

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