Clinical Trial Associate/Sr. Clinical Trial Associate

Company: Arrowhead Pharmaceuticals
Location: Pasadena
Posted on: March 19, 2023

Job Description:

Compensation DescriptionThe base salary range for this position in the selected city is $65,000 - $105,000 annually.The PositionThe 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
• May function as a point of contact between clinical vendors as delegated by Study Lead
• May execute ad hoc study-related administrative tasks assigned by Study Lead
• May participate in SOP/WI development and updatesRequirements:
  • 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 skillsPreferred:
    • 4-year college degree preferred
    • Ability to travel approximately 10% annuallyPowered by JazzHR

Keywords: Arrowhead Pharmaceuticals, Pasadena , Clinical Trial Associate/Sr. Clinical Trial Associate, Healthcare , Pasadena, California