Senior Clinical Research Associate, Field Monitor

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

Why ImmunityBio?
• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

Senior Clinical Research Associate will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies. This role plays a critical ownership part in driving the understanding and delivery of high-quality clinical research (patient safety, data reliability, scientific integrity, and regulatory compliance) by providing expert protocol interpretation, leading proactive risk mitigation leveraging Risk-Based Quality Management (RBQM) principles and providing overall clinical trial support.

Essential Functions

• Execute all visit types (Site Selection, Site Initiation, Routine Monitoring, and Close-out) for assigned clinical trial sites in line with established targets and strategies.
• Conduct remote, risk-based, and on-site monitoring tasks, including source data verification (SDV) and reconciliation of site investigational product (IP) accountability.
• Implement proactive risk identification and mitigation planning aligned with ICH E6(R3) guidelines and RBQM principles. Evaluate site metrics and address deviations before they become systemic issues.
• Interpret medical and scientific intent of assigned study protocols, procedures, logistics, and risks to research subjects.
• Serve as the Subject Matter Expert (SME) for clinical sites, communicating scientific rationale and providing guidance on protocol interpretation, eligibility requirements, and safety reporting.
• Ensure accuracy, validity, and completeness of data collected. Participate in Case Report Form (CRF) data review, resolve complex data queries, and treat protocol deviations as process signals to initiate retraining.
• Oversee and support the collection and maintenance of essential documents in the electronic Trial Master File (eTMF) during study start-up and conduct.
• Drive recruitment and retention strategies, incorporating diversity, equity, and inclusion (DEI) best practices to support sites in meeting enrollment targets.
• Develop, review, and update study-related training materials (e.g., initiation slides, procedures manuals, informed consent templates).
• Work with Supply Chain to ensure sites maintain sufficient IP, resolve temperature monitoring excursions, and coordinate clinical specimen logistics.
• Participate in audit/inspection preparation and drive Corrective and Preventive Action (CAPA) development.
• Provide mentorship and hands-on training to newly hired field and in-house CRAs, fostering a culture of continuous development.
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree required (clinical research, science, or health-related discipline preferred). (Alternatively, a Registered Nurse with a minimum of 5 years of on-site monitoring experience is acceptable, in lieu of a Bachelor’s degree).
• Minimum of 6 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
• Minimum of 4 years of independent on-site and remote monitoring experience required.
• Must possess and maintain a current valid driver's license required

Knowledge, Skills, & Abilities

• Advanced understanding of the drug development