Clinical Trial Site Activation Specialist (Study Start-Up)

Role: Serve as the primary point of contact during clinical trial start-up, focusing on site activation and study initiation within a biopharma setting. Responsibilities: coordinate site identification, regulatory and ethics submissions (IRB/EC), negotiate contracts and budgets, manage essential documentation, and ensure on-time study launch; maintain stakeholder communication and track timelines to meet First Patient In (FPI) targets. Requirements: Bachelor’s degree in life sciences or related field; 2-5+ years of clinical research experience with emphasis on study start-up, regulatory submissions, or site activation, preferably within CRO or pharma environments; solid understanding of GCP, ICH guidelines, and local regulations; proficiency with CTMS, eTMF, and regulatory platforms; strong organizational, multi-tasking, and communication skills. HighValue: clinical trial site activation, start-up process, regulatory and ethics submissions, budgets, documentation management, cross-functional coordination. WorkSetup: hybrid Los Angeles; no travel specified.