Full-Time

Clinical Trial Associate

Posted on 5/16/2024

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

501-1,000 employees

Develops RNAi-based therapies for gene targeting

Biotechnology

Junior

Pasadena, CA, USA + 1 more

Required Skills
Communications
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
Responsibilities
  • Develop and maintain study tools and trackers
  • Update periodic clinical study and portfolio overview reports
  • Route and track approval forms for essential study documents
  • Submit and track study agreements, contracts, budgets for assigned studies
  • Obtain/assign investigative site identification numbers
  • Request country-level clinical trial liability insurance certificates
  • 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
  • Perform TMF filing, including reviews and reconciliation activities
  • Assign and track study specific training for all Clin Ops team members
  • Manage off-site document storage and retrieval as applicable
  • Provide initial and ongoing study information in support of clinical trial registration
  • Execute ad hoc study-related administrative tasks assigned by Study Lead
  • Assist in the planning and coordination of meetings
  • 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

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

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Arrowhead Pharmaceuticals specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.

Company Stage

IPO

Total Funding

$899.9M

Headquarters

Pasadena, California

Founded

2004

Growth & Insights
Headcount

6 month growth

8%

1 year growth

24%

2 year growth

63%
INACTIVE