Lead Clinical Research Associate (Lead CRA)

About this position:

• Job Title: Lead Clinical Research Associate (Lead CRA)
• Department: Clinical
• Reports To: Head, Clinical Operations
• Job location: 100% onsite - Los Angeles, California

Position Summary

The Lead Clinical Research Associate (Lead CRA) serves as the operational lead for a team of Clinical Research Associates and provides oversight of clinical site monitoring activities across one or more clinical trials. The Lead CRA will also have direct site level monitoring responsibilities. The Lead CRA ensures consistent execution of monitoring plans, maintains high standards of data quality and regulatory compliance, mentors CRAs, and serves as the primary monitoring liaison between Clinical Operations, study management, vendors, and investigators.

The Lead CRA is expected to independently manage complex sites while providing leadership, coaching, quality oversight, and issue escalation for the monitoring team.

Key Responsibilities:

• Manage complex clinical sites and support study timelines and goals
• Serve as a point of contact for vendors, site personnel, and internal stakeholders
• Assist with vendor management, site budgets and contract negotiations
• Lead the monitoring activities for assigned clinical studies
• Perform site monitoring activities
• Ensure monitoring activities are performed according to the protocol, monitoring plan, ICH E6 (R3), FDA regulations and company SOPs
• Serve as the primary resource for CRAs regarding protocol interpretation and monitoring expectations
• Review CRO monitoring performance metrics and KPIs, ensuring consistency between sponsor and vendor monitoring activities
• Ensure assigned sites remain inspection-ready throughout the study
• Support FDA and sponsor audits and regulatory inspections
• Lead implementation of risk-based monitoring activities and recommend monitoring adjustments based on emerging study risks
• Review protocol deviations, monitoring findings, CAPAs and corrective actions to identify quality trends across investigative sites
• Onboard, Mentor and coach CRA personnel
• Develop and deliver study-specific monitoring training
• Conduct co-monitoring visits with new CRAs
• Review monitoring reports for quality and consistency
• Standardize monitoring practices across the team
• Assist with workload planning and site assignments
• Manage investigative sites and conduct SQV, SIVs and IMVs, as required
• Monitor study performance metrics including enrollment, query aging, monitoring report timeliness and issue resolution
• Develop mitigation plans with clinical team and quality assurance members
• Perform other duties as assigned.

Qualifications:

Required

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or another scientific discipline
• 7-10 years of clinical research experience
• Minimum 5 years of independent monitoring experience
• Phase II and Phase III trial experience
• Strong knowledge of ICH E6 (R3)
• Experience with CTMS/EDC/eTMF
• Experience leading monitoring teams or serving as a Lead CRA
• Experience managing high-enrolling and complex investigative sites
• Demonstrated leadership and mentoring abilities
• Strong project management and organizational skills
• Excellent written and verbal communication skills
• Strong analytical and problem-solving skills
• Proficiency with Microsoft Office applications

Preferred

• Infectious disease experience
• Biologics or gene/phage therapy experience
• ACRP/CCRA certification
• Sponsor and CRO experience
• FDA inspection experience

Travel Requirements

• Approximately 40-60% travel, depending on study needs
• Ability to travel domestically as required
• Availability for occasional evening or weekend work during critical study milestones

Salary Range: The annual salary range for this position is $112,000-140,000. Actual compensation will be based on qualifications, experience, education, skills, and business needs. This range represents the company's good-faith estimate of the expected compensation for the role at the time of posting.

Armata offers an excellent benefits package designed to support employees' health, financial well-being, and work-life balance. Benefits include comprehensive health insurance options, including medical, dental, and vision coverage; a flexible spending account (FSA); life insurance; short-term and long-term disability insurance; paid holidays; vacation and sick days; a 401(K) plan with employer match; and participation in an equity incentive plan.

About Armata Pharmaceuticals, Inc.:

Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.

Armata is proud to be an Equal Opportunity and Affirmative Action Employer. We are committed to providing equal employment opportunities to all qualified applicants, regardless of race, color, religion, sex (including sexual orientation and gender identity), national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you are interested in applying for the position, please submit your resume with cover letter to careers@armatapharma.com.

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