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16 days old

Contract In-House CRA - Remote in CA

Kelly Services
Irvine, CA 92604 Work Remotely
Kelly is currently seeking Clinical Research Associate for one of our global pharmaceutical clients located in Irvine CA. This role is a full-time, with expectation to start 1/2021 and expected to run for 6 months with possibility to extend. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. This candidate should be home based located within the Southern CA region and could be expected to travel nationwide up to 30% if needed for co-monitoring.





**Clinical Research Associate**



This Clinical Research Associate 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.



Under general direction and in accordance with all applicable federal, state and local laws/regulations and client, procedures and guidelines, this position:




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

+ Participate in the 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)

+ Assist in the 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

+ Coordination and execution of ordering, tracking, and managing investigational products and trial materials

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

+ Assist in overseeing the development and execution of Investigator agreements and trial payments

+ Assist in 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

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

+ 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

+ Assist in tracking assigned project budgets

+ 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

+ Performs other duties assigned as needed

+ Manages work with supervision dependent on project complexity

+ Independent decision-making for simple situations but required guidance for complex situations





**REQUIRED KNOWLEDGE, SKILLS**




+ 3+ years of clinical trial management/support experience including data base lock experience

+ Experience within PMA (Premarket Approval) and NDA filing experience preferred

+ 3+ years experience managing multiple sites and vendor management experience

+ Remote monitoring experience preferred

+ Ability to travel up to 30% if required




+ Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations

+ Presentation and technical writing skills as well as strong written and oral communication skills

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




**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: 2020-11-11 Expires: 2020-12-12

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Contract In-House CRA - Remote in CA

Kelly Services
Irvine, CA 92604

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