Senior Clinical Research Associate, Field Monitor

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $128k - $140k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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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 Site Selection, Site Initiation, Routine Monitoring, and Close-out visits for assigned clinical trial sites • Conduct remote, risk-based, and on-site monitoring, including source data verification and investigational product accountability reconciliation • Identify and mitigate risks using ICH E6(R3) and Risk-Based Quality Management principles • Evaluate site metrics and address deviations • Interpret study protocols, procedures, logistics, and risks to research subjects • Serve as subject matter expert for clinical sites and provide protocol, eligibility, and safety-reporting guidance • Ensure accuracy, validity, and completeness of collected data • Review Case Report Form data and resolve complex data queries • Use protocol deviations as process signals to initiate retraining • Oversee essential document collection and maintenance in the electronic Trial Master File • Drive recruitment and retention strategies, including diversity, equity, and inclusion best practices • Develop, review, and update study-related training materials • Coordinate investigational product supply, temperature excursion resolution, and clinical specimen logistics • Participate in audit and inspection preparation and drive CAPA development • Mentor and train newly hired field and in-house CRAs • Perform ad-hoc and cross-functional duties and projects

🎯 Requirements

• Bachelor’s degree required in clinical research, science, or a 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 • Advanced understanding of the drug development process and medical terminology • Knowledge of current ICH-GCP E6(R3) principles and the Code of Federal Regulations • High proficiency in EDC, eTMF, CTMS, MS Office Suite, and Adobe • Excellent written, oral, and persuasive presentation skills in English • Strong organizational, multitasking, detail orientation, and time management capabilities • Ability to make data-backed decisions and provide guidance on complex issues • Ability to build trust across functions, maintain composure under pressure, and demonstrate an inclusive mindset • Adherence to company Standard Operating Procedures and corporate confidentiality • Ability to travel 50–75% of the time, including overnight travel • Ability to successfully complete a motor vehicle record check upon hire and annually thereafter

🏖️ Benefits

• Discretionary bonus • Equity award • 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 • Employee Discounts, Rewards and Perks • Paid Time Off (PTO), including 11 Holidays • Unlimited PTO for exempt employees • 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day for non-exempt employees • Flexible hours to accommodate various time zones and site locations • Professional development opportunities