INACTIVE
Full-Time
Clinical Trial Associate
Posted on 4/5/2024
Develops RNAi-based therapies for diseases
Biotechnology
Compensation Overview
$75,000 - $105,000Annually
+ Competitive salaries + Excellent benefit package
Junior, Mid, Senior
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 provided to senior management
- 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 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
- 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
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
↑ 9%1 year growth
↑ 27%2 year growth
↑ 63%INACTIVE