IB Temporary - Senior CRA, Field Monitor

Benefits

Additional Information

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 IB Temporary - Senior CRA, Field Monitor 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 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 Collect study and site metrics and maintain study trackers, as needed Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits Partner with field CRAs 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 Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed Provide mentorship and training to newly hired research staff. Performs other duties as assigned. Education & Experience Bachelor's degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting required; or High school diploma with 8 years of experience in a clinical research setting required Minimum of 2 years' experience as a Clinical Research Associate II or higher required Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Strong organizational and multi-tasking skills Understand the job-specific system, processes as defined by the company's SOPs, and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager. Maintain corporate confidentiality at all times Ability to set priorities and independent decision making Ability to work independently as well as in teams Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues 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 Envir