Clinical Trial Associate

Full Time On-Site/Hybrid Operations CTA Clinical Trial 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 Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical trial planning and execution.

Responsibilities

• Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies
• Set-up and maintain TMF in compliance with SOPs/work instructions (WIs) and TMF plans
• Execute TMF filing, reviews and reconciliation activities, including follow-up on QA/QC findings
• Manage off-site document storage and retrieval as applicable
• Submit and track purchase orders, study agreements and contracts for assigned studies
• Route approval forms for essential study documents (eg informed consent, study plans, etc.).
• Provide initial and ongoing study information in support of clinical trial registration (eg Clinical Trials.gov)
• Request country-level clinical trial liability insurance certificates for assigned studies
• Assist in the planning and coordination of meetings including logistics, agenda preparation and distribution of meeting minutes and meeting materials
• Participate in Clinical Operations department initiatives and other duties as assigned.
• Recommend modifications to SOPs/WIs when necessary to improve compliance or efficiency
• Comply with assigned SOPs/WIs and applicable plans, guidelines and standards

Requirements:

• At least 1 year experience in similar industry position or equivalent work experience
• Strong organizational skills and attention to detail
• Ability to multi-task and prioritize effectively with input from manager or Study Lead
• Proficient interpersonal, verbal and written communication skills
• Ability to work effectively independently and in a collaborative team environment
• Basic software skills (MS-Outlook, Word, Excel, DocuSign)
• Proficiency in Veeva eTMF
• Ability to perform Key Duties and Responsibilities in a timely manner and with minimal supervision
• Basic understanding of Good Documentation Practice (GDP) and ICH-GCP
• Ability to readily identify and categorize essential document types as defined by ICH E6 for submission to TMF
• Consistently exhibits critical thinking skills

Preferred:

• 4-year college degree preferred

California pay range

$65,000—$105,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

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