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. The PositionThe 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.  ResponsibilitiesSupport assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documentsRoutinely monitor TMF inspection readiness for assigned studiesAssist Study Lead in review of invoices for assigned studiesContribute to development and finalization of Pharmacy Manual and associated forms, templates and processesAssist study lead with investigational product and ancillary supplies management, accountability and reconciliation activitiesSupport IRT system set-up, testing, and on time activation including review of specifications, and user manuals.Collect and/or review Essential Documents from investigational sitesReview site-level ICFs for accuracy and complianceLead study specific tasks such as investigator identification, feasibility, and site activationReview monitoring visit reports for accuracy and completenessAttend or conduct site selection, initiation interim monitoring visits, close-out visits and co-monitoring oversight visitsContribute 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 executionProvide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or equivalentPerform periodic data review as requested by the Study LeadSupport 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 LeadCoordinate 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 membersIdentify, and lead process improvement projects within the Clinical Operations departmentRecommend modifications to SOPs/work instructions (WIs) when necessary to improve compliance or efficiencyMaintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements.May Assist TA Management in program level projects as assignedMay 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 budgetsMay contribute to the development of protocols, amendments, clinical study/periodic reports and investigator brochuresMay serve as a main point of contact and coordination for internal and external stakeholders on assigned trials for specific activities and major deliverablesRequirements5 years in clinical research and development3 years onsite monitoring/site management experienceExperience managing/supervising vendorsHighly proficient knowledge and understanding of ICH-GCPPreferred4-year college degreeCRA certificationStrong organizational skills and attention to detailExcellent site management and monitoring skillsProficient software skills (Outlook, Word, Excel, Power Point, MS Project)Proficient in Veeva eTMF and Medidata EDCAbility to perform key duties in a timely manner and with minimal supervisionAbility to think critically (analyze, extrapolate knowledge and information and problem-solve)Ability to work effectively independently and in a collaborative team environmentMust be able to work collaboratively and professionally with team members and outside vendors such as CROsExcellent interpersonal, verbal and written communication skillsAbility to multi-task and prioritize appropriatelyDisplays high level of professionalism and understands need for confidentiality in all aspects of positionCalifornia pay range $125,000—$135,000 USDArrowhead provides competitive salaries and an excellent benefit package. 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