RoleLead Clinical Research Associate (Lead CRA) overseeing site monitoring activities for clinical trials at Armata Pharmaceuticals, with operational leadership and mentorship responsibilities.
Responsibilitiesmanage 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
Preferredinfectious disease, biologics, gene/phage therapy experience
ACRP/CCRA certification
FDA inspection experience
HighValuebiologics
bacteriophage therapeutics
Phase II/III
FDA/compliance focus
Work Setup 100% onsite in Los Angeles
approximately 40-60% travel
