Senior Clinical Research Associate, Field Monitor
Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
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/in