Senior Clinical Research Associate

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.

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 Clinical Trials.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, etc.) set-up and on-time activation (e.g. specifications, user manuals, etc.) as delegated by the Study LeadWork closely with CRO to plan for execution of study start-up and ongoing study execution activities as assigned by the Study Lead. Provide guidance, mentorship and oversight to more junior Clinical Operations staff members Identify, and lead process improvement projects within the Clinical Operations department Recommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or efficiency Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements. May Assist TA Management in program level projects as assigned May represent Clinical Operations in cross-functional initiatives as assigned by management. May assist clinical finance and study lead with the review, and management of study specific budgets May contribute to the development of protocols, amendments, clinical study/periodic reports and investigator brochures May serve as a main point of contact and coordination for internal and external stakeholders on assigned trials for specific activities and major deliverables

California pay range $125,000—$135,000 USDArrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy