Lead Clinical Research Associate (Lead CRA)

Role: Lead Clinical Research Associate (Lead CRA) overseeing site monitoring activities for clinical trials at Armata Pharmaceuticals, with operational leadership and mentorship responsibilities. Responsibilities: manage complex investigational sites, lead monitoring efforts, ensure compliance with ICH E6 (R3), FDA regulations, and SOPs; support vendor management, site onboarding, training, and performance review; facilitate audits and regulatory inspections; implement risk-based monitoring strategies; review deviations, CAPAs, and study metrics; mentor and coach CRAs. Requirements: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field; 7-10 years of clinical research experience, with at least 5 years in independent monitoring, including Phase II/III trials; proficiency in CTMS, EDC, eTMF; leadership and mentoring skills; strong organizational, communication, and problem-solving abilities. Preferred: infectious disease, biologics, gene/phage therapy experience, ACRP/CCRA certification, FDA inspection experience. HighValue: biologics, bacteriophage therapeutics, Phase II/III, FDA/compliance focus. WorkSetup: 100% onsite in Los Angeles; approximately 40-60% travel. The role emphasizes leadership in high-enrolling, complex sites within a biotech developing pathogen-specific therapies.