Senior Clinical Research Associate, Field Monitor

🕒 July 24

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree required (clinical research, science, or health-related discipline preferred) • 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

🏖️ 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