Clinical Research Associate, In-House at ImmunityBio

Job description

Company Overview 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. 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 a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary 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