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24 days old

Sr. Clinical Research Associate

Kelly Services
Irvine, CA 92604
**Senior Clinical Research Specialist**


Kelly is currently seeking a Senior Clinical Research Specialist for one of the top global pharmaceutical companies in the world. This opportunity is directly supporting our client and does not have an end date expectation. The opportunity can be home based with expectations to travel into Irvine to site as needed. This opportunity is ongoing with no end date and offers our enhanced benefit package options including medical, dental, vision insurance options as well as paid time off, vacation pay and 401k option.



This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.



**DUTIES & RESPONSIBILITIES**




+ Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones

+ Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures

+ May serve as the primary contact for clinical trial sites (e.g. site management)

+ Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,.), ensure registration on www.clinicaltrials.gov from study initiation through posting of results and support publications as needed

+ Management/oversight of ordering, tracking, and accountability of investigational products and trial materials

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

+ Oversee the development and execution of Investigator agreements and trial payments

+ Responsible for clinical data review to prepare data for statistical analyses and publications

+ If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need

+ May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects

+ If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center

+ Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated

+ Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs)

+ Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders

+ Support project/study budget activities as assigned

+ Develop a strong understanding of the pipeline, product portfolio and business needs

+ Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures



**Qualifications:**




+ Minimum of a bachelors degree preferably in Life Science, Physical Science, Nursing, or Biological Science required

+ 4 years of clinical research study support experience required

+ Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)

+ Medical device experience highly preferred

+ Neurovascular clinical trial experience preferred




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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. 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.

\#KellyGTS

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Posted: 2020-10-05 Expires: 2020-11-26

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Sr. Clinical Research Associate

Kelly Services
Irvine, CA 92604

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