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15 days old

Clinical Trial Specialist

Kelly Services
Irvine, CA 92604
Kelly is currently seeking a Clinical Trial Specialist for a long-term engagement with one of our Global Medical Device clients in Irvine, CA.



This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. 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.






**RESPONSIBILITIES**



+ Serves as a Clinical Trial Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises

+ Serves as a member of the clinical trial/study core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility

+ May serve as the primary contact for clinical trial sites

+ Manage operational activities of assigned clinical studies within the Clinical R&D Operations group

+ Solves problems with support from Clinical Management arising during clinical trial execution

+ Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders

+ May be involved in other tasks to support Clinical R&D Operations and R&D Clinical Franchise as needed

+ Track assigned projects budgets to ensure adherence to business plans

+ Support the implementation of new clinical systems/processes, and provide support for publications, as needed.

+ Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel

+ Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance



+ Ensure efficient use of resources within the clinical study/program to provide high quality deliverables.






Business Leadership Responsibilities:



+ Accountable for quality, compliance with regulations and company procedures, timelines, and budgets for assigned clinical trials.

+ May lead several non-regulated small clinical trials and/or a small number of non-regulated medium trials that may involve other clinical operations staff (i.e., <150K USD annual investment).

+ May assist with the management of large regulated or complex trials under supervision of CTM or Senior CTM.

+ Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical trials under his/her responsibilities.






**QUALIFICATIONS**






+ Minimum of a Bachelors/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, or Biological Science.

+ 2-4 years of relevant experience (or equivalent) required.

+ Previous experience in clinical trial management or equivalent is desired.

+ Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).

+ Clinical/medical background a plus.

+ Medical device experience a plus.

+ Requires understanding of Good Clinical Practices

+ Understanding and application of regulations and standards applied in clinical areas/regions is required

+ Presentation skills and influencing of others

+ Written and oral communication skills

+ Demonstrated competencies in the following areas are required:

+ Behaving in a professional and ethical manner

+ Technical writing skills






**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: 2021-04-23 Expires: 2021-05-24

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Clinical Trial Specialist

Kelly Services
Irvine, CA 92604

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