Clinical Research Associate, In-House

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient’s immune system and treat the host rather than just the disease.

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 will 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

• Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
• Track and maintain ImmunityBio study personnel list and training records for assigned studies
• Communicate study rationale for assigned studies to study team members and clinical sites
• Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
• Create/edit site feasibility questionnaire template, track feasibility/start-up activities
• Create regulatory document templates, oversee and support collection of essential documents during site start-up
• 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
• Partner with field CRAs and CTAs to resolve document issues identified during site visits
• Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
• 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
• File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
• Perform content review and post approval review of documents filed to the TMF
• Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
• Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
• 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, create and manage site shipping accounts
• Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accou