Clinical Research Specialist/Medical Device

2 weeks ago

Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Science and Clinical FSP is currently seeking a Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This is a hybrid position. 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, Vision, 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 Research 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.,

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