Clinical Research Associate (CRA)

Job Title: Clinical Research Associate (CRA)

Department: Clinical

Reports To: Lead CRA

Job location: 100% onsite - Los Angeles, California

Position Summary

The Clinical Research Associate independently manages assigned investigative sites and is responsible for monitoring clinical trials to ensure subject safety, data quality, protocol compliance, and adherence to applicable regulatory requirements. The CRA serves as the primary operational contact for assigned sites, conducts monitoring visits throughout the study lifecycle, and works collaboratively with cross-functional teams to ensure successful study execution.

The CRA operates with minimal supervision while escalating significant issues to the Lead CRA.

Key Responsibilities:

• Independently conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Remote Monitoring Visits (RMVs), For-Cause Visits and Close-out Visits (COVs)
• Ensure clinical sites comply with the protocol, Monitoring Plan, ICH E6(R3), FDA regulations, company SOPs, and applicable regulatory requirements
• Verify subject eligibility, informed consent, protocol compliance, and source documentation
• Perform Source Data Verification (SDV) and Source Data Review (SDR) according to the Monitoring Plan
• Review adverse events (AEs), serious adverse events (SAEs), protocol deviations and safety documentation
• Prepare complete and timely monitoring reports and follow-up letters
• Track and resolve monitoring findings, action items and data queries
• Serve as the primary operational contact for assigned investigative sites
• Develop effective working relationships with investigators and study coordinators
• Monitor enrollment, protocol compliance, data quality, query aging and overall site performance
• Provide protocol and study procedure training to site personnel as needed
• Escalate significant operational, compliance or safety issues promptly
• Monitor data quality and protocol adherence
• Identify operational risks and recommend corrective actions
• Support implementation of Corrective and Preventive Actions (CAPAs)
• Maintain assigned sites in an inspection-ready state and support sponsor audits and regulatory inspections, as required
• Collaborate with Lead CRA, Clinical Operations, Data Management, Medical monitoring, Regulatory Affairs, Quality Assurance and Pharmacovigilance, Clinical Supply and Biostatistics

Qualifications:

Required

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or another scientific discipline
• 3-5 years of clinical research experience
• Minimum 2 years of independent monitoring experience
• Experience conducting routine monitoring visits independently
• Phase II and Phase III trial experience
• Strong knowledge of ICH E6 (R3)
• Experience with CTMS/EDC/eTMF
• Experience with independently managing multiple investigative sites
• Demonstrated ability to collaborate effectively with cross-functional teams
• 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 or hospital-based clinical trial experience
• Experience with biologics, cell/gene therapy or bacteriophage therapeutics
• ACRP/CCRA certification
• Sponsor and CRO experience
• FDA inspection experience

Travel Requirements

• Approximately 60-70% travel, depending on study needs
• Ability to travel domestically as required
• Flexibility to travel short notice when necessary
• Availability for occasional evening or weekend work during critical study milestones

Salary Range: The annual salary range for this position is $86,200 - 113,000. 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.

Close