Senior Clinical Research Associate at Arrowhead Pharmaceuticals in San Diego, CA

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Sr. Clinical Research Associate (Sr. CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures. Responsibilities Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents Routinely monitor TMF inspection readiness for assigned studies Assist Study Lead in review of invoices for assigned studies Contribute to development and finalization of Pharmacy Manual and associated forms, templates and processes Assist study lead with investigational product and ancillary supplies management, accountability and reconciliation activities Support IRT system set-up, testing, and on time activation including review of specifications, and user manuals. Collect and/or review Essential Documents from investigational sites Review site-level ICFs for accuracy and compliance Lead study specific tasks such as investigator identification, feasibility, and site activation Review monitoring visit reports for accuracy and completeness Attend or conduct site selection, initiation interim monitoring visits, close-out visits and co-monitoring oversight visits Contribute to the development of study-level documents (study templates, manuals, guides, newsletters, case report forms (CRFs), study master informed consent forms, study-level forms and reference materials, etc.) Assist in the preparation and review of site-level forms and templates (eg screening/enrollment logs, site signature/responsibilities form, site monitoring log, etc.) Assist in the preparation of training materials and presentations related to study execution Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or equivalent Perform periodic data review as requested by the Study Lead Support Study Lead in preparing materials for study-wide meetings (eg investigator meetings, interim update meetings, data safety committee meetings, etc.) Prepare and present updates at team meetings as assigned by Study Lead Coordinate external service provider (e.g. central lab, recruitment, homecare, e