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Clinical Research Specialist

Clinical Research Specialist

RedBrick StaffingOrange County, CA, US
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Job Description

Job Responsibilities :

  • Manage & coordinate in-house clinical ops
  • Act as site manager and company interface for active studies
  • Responsible for site regulatory document collection, filing of study documents in trial master file (TMF), ICF review / approval, IRB / EC submission (including annual submissions), payments tracking, study supply management (as appropriate), study communication, field training and support
  • Responsible for implementation of clinical study documents as needed, including but not limited to : ICFs, amendments to study protocols, SOPs, Work Instructions (WIs) and study-specific forms, to ensure appropriate compliance with site start-up and initiation process and applicable regulations
  • Review sample, investigator-prepared and IRB-approved informed consents
  • Support the design, format and content of study guides and subject instructions
  • Coordinate activities associated with site startup
  • Interface with in-house data and EDC / CTMS management to ensure seamless study execution
  • Support clinical dossier preparation for CEC meetings
  • Support prep of clinical sites for regulatory inspections
  • Partner with and work cross-functionally with various team members

Job Requirements :

  • 4+ years prior experience in clinical ops role – experience in Med Device or Spine industry strongly preferred
  • Ability to travel for monitoring or as requested by the study team
  • Strong project management skills with an entrepreneurial attitude
  • Proficient with clinical trial management software including EDC, eTMF, CTMS
  • Prior experience with IDE clinical trial and international regulatory process required including FDA; ICH and ISO : 14155.
  • Strong communication & problem-solving skills
  • Self-motivated, team player, with excellent time management skills
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