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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/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 process, medical terminology, current ICH-GCP E6(R3) principles, and the Code of Federal Regulations.
High proficiency in modern clinical trial systems including EDC, eTMF, and CTMS, as well as MS Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe.
Excellent written, oral, and persuasive presentation skills in English, with an outgoing and confident demeanor.
Strong organizational and multi-tasking skills with a high degree of detail orientation and time management capabilities.
Independent thinker with the ability to set priorities, make bold, data-backed decisions, and provide guidance to in-house teams on how to address complex issues.
Demonstrated collaborative skills: ability to build trust across functions, maintain composure under pressure, and display an inclusive mindset respecting diversity in internal and external teams.
Strict adherence to company Standard Operating Procedures (SOPs) and corporate confidentiality. If any procedure or process requirements are unclear, it is the responsibility of the employee to notify their supervisor or manager.
Working Environment / Physical Environment
Must be able to travel up to 50-75% of the time (including overnight travel) based on study requirements.
Remote with the ability to work flexible hours to accommodate various time zones and site locations.
Must successfully complete a motor vehicle record check upon hire and annually thereafter
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$128,000 (entry-level qualifications) to $136,000 (highly experienced) annually
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$133,000 (entry-level qualifications) to $140,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.
Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.
We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.