Clinical Research Associate; in-house

Overview

About Artiva:
Artiva is 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. This includes 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), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases.

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, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva 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. They will identify issues in a timely manner and escalate to management as appropriate.

The CRA may complete monitoring visit report review and perform co-monitoring. The core duties and responsibilities of the CRA are delineated below.

• Organizes, and supports trial managers, in conduct of all study team via agenda and meeting minute preparation, completion and distribution.
• Manages Site Essential Documents review during study start-up, maintenance and close-out period
• Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
• Ensures tracking and filing of essential documents in the appropriate tracking systems.
• Ensures tracking of patient status throughout the study at investigative sites
• Responsible for maintaining internal tracking systems of patient and site status in support of trial and management needs.
• May review and approve trip reports, track data query reports, site visit metrics, and overall site performance
• May perform routine monitoring at limited clinical sites
• May perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with local CRAs
• Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
• May assist in the preparation of, and may present at investigator vendor meetings and workshops
• Actively involved in the performance of study feasibility assessments
• Provides rapid action to address both internal and site QA findings from audits
• Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
• Routinely participates in department and clinical trial team meetings and participates in collaborative efforts (e.g. protocol development, CRO selection, departmental initiatives, etc.)

• Bachelors degree or higher
• 3 or more years industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 year of site or hospital experience
• Previous site monitoring experience preferred
• Working knowledge in Good Clinical Practices (GCP) regulations and Standard…