Clinical Research Associate; in-house

About Artiva

Artiva is a clinical‑stage, publicly‑traded biotechnology company focused on developing natural killer (NK) cell‑based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program,
AlloNK®, is an allogeneic, off‑the‑shelf, non‑genetically modified NK cell therapy candidate designed to enhance the antibody‑dependent cellular cytotoxicity effect of monoclonal antibodies to drive B‑cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B‑cell‑driven autoimmune diseases. These include two company‑sponsored trials—one in systemic lupus erythematosus for patients with or without lupus nephritis—and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies, and Sjögren’s Disease). An investigator‑initiated basket trial is also underway. Artiva’s pipeline also includes CAR‑NK candidates targeting both solid and hematologic cancers.

Artiva was founded in 2019 as a spin‑out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea. A strategic partnership granted Artiva exclusive worldwide rights—excluding Asia, Australia and New Zealand—to GC Cell’s NK cell manufacturing technology and programs. The company is headquartered in San Diego, California.

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The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(s). The CRA works closely with the clinical trial team to ensure site‑related start‑up through close‑out activities are conducted according to Good Clinical Practice (GCP) and relevant SOPs. The CRA may assist with vendor oversight and management, identify issues in a timely manner and elevate them to management, review monitoring visit reports, and perform co‑monitoring.

• Organize and support trial managers in conduct of all study team activities via agenda and meeting minute preparation, completion, and distribution.
• Manage Site Essential Document review during study start‑up, maintenance, and close‑out.
• Prepare study documents (consent forms, site instructions, study‑specific materials such as the Manual of Operations, pharmacy binder, etc.).
• Ensure tracking and filing of essential documents in the appropriate tracking systems.
• Track patient status throughout the study at investigative sites.
• Maintain internal tracking systems of patient and site status to support trial and management needs.
• Review and approve trip reports, data query reports, site visit metrics, and overall site performance.
• Perform routine monitoring at limited clinical sites.
• Perform site initiation, routine monitoring, and close‑out visits at a limited number of clinical sites, and co‑monitor with local CRAs.
• Ensure quality of the data generated from clinical sites and assist in resolving subject eligibility and protocol deviation issues.
• Assist with preparation of, and may present at, investigator vendor meetings and workshops.
• Actively engage in performance of study feasibility assessments.
• Provide rapid action to address internal and site QA findings from audits.
• Coordinate activities from third‑party vendors, including metrics, accruals, process planning, and implementation.
• Participate in department and clinical trial team meetings and collaborate on initiatives (e.g., protocol development, CRO selection, departmental initiatives, etc.).

• Bachelor’s degree or higher.
• Three or more years of industry experience from Pharmaceutical, Biotechnology, or Contract Research Organization (CRO), including at least one year of site or hospital experience.
• Previous site monitoring experience preferred.
• Working knowledge of Good Clinical Practice (GCP) regulations and Standard Operating Procedures.
• Understanding of study phases and general knowledge of how they apply to clinical development.
• Advanced knowledge of Word, Excel, and PowerPoint.
• Knowledge of principles and…