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Clinical Research Associate, In-house
4 months ago
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
- 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, PowerPoi
