ImmunityBio, Inc. is a late-stage immunotherapy company developing a broad pipeline of next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.” The U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and has set a user fee goal date (PDUFA date) of April 23, 2024. 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 an early-stage public biopharmaceutical company with a headquarters in Southern California. · Work with a collaborative team with the ability to work across different areas at the company. · Ability to join a growing company with development opportunities. Position Summary Participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support. Essential Functions Develop, review, and update study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc. Communicate scientific rationale for assigned studies to team members and clinical sites Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements Create/edit, distribute and collect site feasibility questionnaires Oversee and support collection of essential documents during study start-up Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Collect study and site metrics and maintain study trackers, as needed Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits Partner with field CRAs and CTAs to resolve issues identified during site visits Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors Conduct remote monitoring tasks including reconciliation of site investigational product accountability Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission. Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee. Provide data listings and compile clinical study report documents to support medical writing activities Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations Participate in clinical operations safety reporting activities including distribution to sites, tracking, IRB submission and filing Compile and prepare clinical trial information for IRB reporting and submission Prepare and deliver reports and presentations to Senior Management on study metrics and clinical trial status. Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are conducted efficiently, compliant with regulations and standards, and aligned with project objectives Assist Clinical Trial Manager (CTM) with management of trial aspects as delegated by the CTM Performs other duties as assigned. Education & Experience Bachelors degree with 4 year experience as a Clinical Trials Associate; or Associate’s degree with 7 years’ experience as a Clinical Trials Associate; or 10 years clinical research experience Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills Strong organizational and multi-tasking skills Maintain corporate confidentiality at all times Ability to set priorities and independent decision making Ability to work independently as well as in teams Strong oral and written communication skills Outgoing and confident demeanor Independent thinker and persuasive communicator Detail oriented, with solid organization and time management skills Completes projects with reliability and minimal guidance Knowledge of drug development process Computer literacy: EDC, eTMF, CTMS, etc. Working knowledge of ICH E6, and the Code of Federal Regulations Working Environment / Physical Environment This position works on site 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. $77,000 (entry-level qualifications) to $95,000 (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 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. ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed. ImmunityBio is a leading registration-stage immuno-oncology and infectious disease company activating both the innate (natural killer cell and macrophage) and adaptive (T cell) immune system. We are developing molecular and product platforms including N-803, Aldoxorubicin, and a second-generation adenovirus vector, based upon our three key modalities of activating natural killer (‘NK’) and T cells, tumoricidal macrophages, and memory T cells.