Senior Clinical Research Associate, Field Monitor

ImmunityBio, Inc.•El Segundo, CA

9d•$128,000 - $140,000•Remote

About The Position

The 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.

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 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
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.

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 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.

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 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