Clinical Trial Associate - San Diego
3 days ago
Job description
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 & 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 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 and trackers (e.g., study contact lists, study vendor contract tracking, site visit report completion, sample management)
- Update periodic clinical study and portfolio overview reports provided to senior management
- Route and track approval forms for essential study documents (e.g., informed consent, study plans, etc.)
- Submit and track study agreements, contracts, budgets for assigned studies
- Obtain/assign investigative site identification numbers
- Request country-level clinical trial liability insurance certificates for assigned studies
- Provide Regulatory Affairs with copies of the 1572/Investigator Statement of Compliance and Financial Disclosures
- Request study set-up in Veeva Vault and system access for study team members
- Collaborate with eTMF Owner to draft and finalize the eTMF Plan and Expect Document Lists (EDLs)
- Perform TMF filing, which may include reviews and reconciliation activities
- Assign and track study specific training for all Clin Ops team members based on the core curriculum
- Manage off-site document storage and retrieval as applicable
- Provide initial and ongoing study information in support of clinical trial registration (e.g., Clinical )
- Execute ad hoc study-related administrative tasks assigned by Study Lead
- 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
- In addition to Key Duties and Responsibilities:
- May perform QC (formatting, spelling, grammar, accuracy, consistency) of study related documents (ICFs, study plans, etc.) in alignment with study protocols
- May contribute to the development of study related documents (study plans, study templates, investigator site file materials, newsletters, etc.)
- May function as a point of contact between clinical vendors as delegated by Study Lead
- May participate in SOP/WI development and revisions
Requirements
- 1 year of experience in similar industry position
- Basic understanding of Good Documentation Practice (GDP) and ICH-GCP
- Pharmaceutical or biotechnology environment experience and valued but not mandatory
- 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)
- Ability to perform Key Duties and Responsibilities in a timely manner and with minimal supervision
- Proficiency in Veeva eTMF
Preferred
- 4-year college degree preferred
- Ability to readily identify and categorize essential document types as defined by ICH E6 for submission to TMF
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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