Sr. Clinical Research Associate

Full Time On-Site/Hybrid Operations CRA Clinical Research Associate Apply for this Job Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. 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 the Clinical Operations Manager (COM)/Study Lead(s) to manage and track key study deliverables. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, and closeout to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines. This is primarily an in-house role.

Responsibilities

• Support Study Lead to execute study milestones against study timelines
• Tracking of key deliverables during start-up, study maintenance and close-out; generate, review and distribute reports from internal tracking at requested intervals (Site Status, Enrollment, Dosing)
• Collaborate with the Study Lead to develop/review certain study-specific plans and/or processes
• Present updates at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collect and review essential documents from investigational sites
• Support CTAs with TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participate in study specific tasks such as investigator identification and site activation
• Contribute to the development/review of study specific Monitoring Plans; track timing/planning of site visits to ensure compliance
• Contribute to the development/review of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Review monitoring visit reports and perform occasional co-monitoring visits with CRO CRAs
• Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Act as CROs’ CRA/CTA first line of contact for study related questions/issues
• Work with the CRO to arrange and prepare for Site Qualification Visits, Site Initiation Visits and Site Investigator Meetings (as applicable)
• Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on ClinicalTrials.gov or EU equivalent
• Assist Study Lead with design and preparation of study related materials for the training of CRO staff
• Assist Study Lead with oversight of study vendors (CRO, Drug Supply, Central Lab) as required
• Perform remote query and data review as needed to assist CDM
• Assist clinical finance and study lead with the review, tracking and management of study specific budgets

Requirements:

• 4-year college degree (preferred) otherwise, candidates with a combination of education and relevant experience will be considered
• Minimum of five (5) years in clinical research
• Minimum of three (3) years onsite monitoring/site management experience
• Experience managing/supervising vendors
• Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
• Working knowledge of medical terminology
• Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
• Proficient in MS Office (Word, Excel, and PowerPoint)
• Ability to work in a team or independently
• Effective interpersonal, written and verbal communication skills
• Able to critically evaluate job tasks and the impact on overall study execution
• Strong problem-solving capabilities
• Effectively collaborates with Study Team members
• Exceptional organizational skills with the ability to multi-task and prioritize
• Attention to detail
• Ability to work with distributed team members and outside vendors
• Occasional travel in US or overseas (<10%)

Preferred:

• CRA certification

California pay range

$120,000—$140,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.