Clinical Research Associate, In-House

Clinical Research Associate, In-House

ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

The Clinical Research Associate, In-House (IH) will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, support for process improvement, collection of essential documents and overall clinical trial support.

Essential Functions

• Facilitate study specific inspection readiness initiatives including tracking and maintaining ImmunityBio ClinOps study personnel list and training records
• Support development of new process and system implementations that impact assigned studies and IH team functions
• Identify process inefficiencies, gaps and provide process improvement recommendations to Trial Maintenance leadership
• Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
• Review and update study-related materials track feasibility/start-up activities
• Create regulatory document templates, oversee and support collection of essential documents during site start-up and as needed throughout the study
• Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
• File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
• Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
• Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial
• File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
• Perform content review and post approval review of documents filed to the TMF
• Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
• Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers
• Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
• Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
• Submit purchase requisitions to Enterprise Resource Planning (ERP) System
• Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
• 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
• Support clinical operations safety reporting activities including distribution to sites, tracking, IRB submission and related document filing
• Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities

Education & Experience

• Bachelor's degree with 4+ year experience as a Clinical Trials Associate (or 7+ years' clinical research experience) required; or
• Associate's degree with 7+ years' experience as a Clinical Trials Associate (or 10+ years clinical research experience) required

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
• Anticipate issues, identify process gaps and work to proactively and independently provide solutions
• Independent thinker and persuasive communicator
• Detail oriented, with solid organization and time management skills
• 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 in Dunkirk, NY.
• Regular work schedule is Monday Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

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.

$85,000 (entry-level qualifications) to $93,000 (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 uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

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.