Clinical Research Specialist (Orange County)

Job Responsibilities:Manage & coordinate in-house clinical opsAct as site manager and company interface for active studiesResponsible 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 supportResponsible 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 regulationsReview sample, investigator-prepared and IRB-approved informed consentsSupport the design, format and content of study guides and subject instructionsCoordinate activities associated with site startupInterface with in-house data and EDC/CTMS management to ensure seamless study executionSupport clinical dossier preparation for CEC meetingsSupport prep of clinical sites for regulatory inspectionsPartner with and work cross-functionally with various team membersJob Requirements: 4+ years prior experience in clinical ops role experience in Med Device or Spine industry strongly preferredAbility to travel for monitoring or as requested by the study teamStrong project management skills with an entrepreneurial attitudeProficient with clinical trial management software including EDC, eTMF, CTMSPrior experience with IDE clinical trial and international regulatory process required including FDA; ICH and ISO:14155.Strong communication & problem-solving skillsSelf-motivated, team player, with excellent time management skills

Created: 2025-09-22