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Salary: USD 110,000 - 135,000 / annual
Artiva Biotherapeutics is a clinical-stage, publicly-traded biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases and cancers. The company's lead program, AlloNK®, is an allogeneic, off-the-shelf NK cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity. AlloNK is currently being evaluated in three ongoing clinical trials for B-cell driven autoimmune diseases, including systemic lupus erythematosus and a basket trial across rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's disease. Artiva's pipeline also includes CAR-NK candidates targeting solid and hematologic cancers.
The Sr. Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of 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. Key responsibilities include organizing and supporting trial managers in study team conduct via agenda and meeting minute preparation; managing Site Essential Documents review during study start-up, maintenance, and close-out; preparing study documents such as consent forms and site instructions; ensuring tracking and filing of essential documents; tracking patient status throughout studies at investigative sites; maintaining internal tracking systems of patient and site status; reviewing and approving trip reports and site visit metrics; performing routine monitoring at limited clinical sites; performing site initiation, routine monitoring, and close-out visits; ensuring data quality and assisting in resolving subject eligibility and protocol deviation issues; assisting in preparation of and presenting at investigator vendor meetings; actively participating in study feasibility assessments; providing rapid action to address QA findings from audits; coordinating third-party vendor activities; and routinely participating in department and clinical trial team meetings.
The role may include up to 20-30% travel. Artiva emphasizes a collaborative, innovative culture focused on improving the lives of autoimmune and cancer patients.
REQUIREMENTS:
- Bachelor's degree or higher
- 3 or more years of industry experience in Pharmaceutical, Biotechnology, or Contract Research Organization (CRO), including at least 1 year of site or hospital experience
- Previous site monitoring experience preferred
- Working knowledge of Good Clinical Practices (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 practices of computer applications in database management
- Strong verbal and written communication skills required
