Senior Clinical Research Associate, Field Monitor

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s natural immune system, enabling it to outsmart disease and eliminate cancerous or infected cells. Our vision is to conquer cancer by harnessing the power of the human immune system, amplifying both its branches to attack cancer today while building immunological memory for tomorrow. We aim to reprogram the patient’s immune system to treat the host rather than just the disease.

About the role

The Senior Clinical Research Associate will participate in clinical research teams to ensure the effective and efficient conduct of clinical research studies. This role drives high-quality clinical research—focusing on patient safety, data reliability, scientific integrity, and regulatory compliance—through expert protocol interpretation, proactive risk mitigation using Risk-Based Quality Management (RBQM) principles, and overall clinical trial support.

Responsibilities

• 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 the 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.

Requirements

• 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.
• Minimum of 4 years of independent on-site and remote monitoring experience.
• Current valid driver's license required.

Skills

• 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 addressing 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.

Schedule

• 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.

Pay

• National Market (all markets unless identified as Premium): $128,000 (entry-level qualifications) to $136,000 (highly experienced) annually.
• Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $133,000 (entry-level qualifications) to $140,000 (highly experienced) annually.

Benefits

• 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: Unlimited PTO
  • Non-Exempt Employees: 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day