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Clinical Research Associate

Company: Arrowhead Pharmaceuticals, Inc
Location: Pasadena
Posted on: March 20, 2023

Job Description:

The PositionThe Clinical Research Associate (CRA) provides support to the Clinical Operations Manager (COM)/Study Lead(s) to manage and track key study deliverables. The primary purpose of the position is to support the COM/Study Lead to ensure study deliverables are met and compliance with clinical protocols, their objectives and ICH and GCP guidelines.Responsibilities

  • Support Study Lead to execute study milestones against study timelines
  • Tracking of key deliverables during start-up, study maintenance and close-out; generate, review and distribute reports from internal tracking at requested intervals (Site Status, Enrollment, Dosing)
  • Support the Study Lead and contribute to development/review of certain study-specific plans and/or processes
  • Collect and review essential documents from investigational sites
  • Support CTAs with TMF set-up, maintenance, ongoing quality eTMF reviews, and final reconciliation of study documents
  • Support Study lead in study specific tasks such as investigator identification and site activation
  • Contribute to the development/review of study specific Monitoring Plans; track timing/planning of site visits to ensure compliance
  • Contribute to the development/review of study materials, case report forms (CRFs), informed consent documents for clinical studies
  • Perform first round review of monitoring visit reports
  • Assist in the preparation and review of site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
  • Support Study Lead to arrange and prepare for Site Qualification Visits, Site Initiation Visits and Site Investigator Meetings (as applicable)
  • Provide updates on study/site status as needed to ensure timely study entry and updates are reflected on or EU equivalent
  • Assist Study Lead with design and preparation of study related materials for the training of CRO staff
  • Assist Study Lead with oversight of study vendors (CRO, Drug Supply, Central Lab) as required
  • Support Study Lead with data reviews as needed to assist CDM
  • Assist clinical finance and study lead with the review, tracking and management of study specific budgetsRequirements:
    • Minimum of five (5) years in clinical research
    • Minimum of three (2) years site management experience
    • Experience managing/supervising vendors
    • Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
    • Working knowledge of medical terminology
    • Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
    • Proficient in MS Office (Word, Excel, and PowerPoint)
    • Ability to work in a team or independently
    • Effective interpersonal, written and verbal communication skills
    • Able to critically evaluate job tasks and the impact on overall study execution
    • Strong problem-solving capabilities
    • Effectively collaborates with Study Team members
    • Exceptional organizational skills with the ability to multi-task and prioritize
    • Attention to detail
    • Ability to work with distributed team members and outside vendors
    • Occasional travel in US or overseas (Preferred:
      • 4-year college degree
      • CRA certification

Keywords: Arrowhead Pharmaceuticals, Inc, Pasadena , Clinical Research Associate, Healthcare , Pasadena, California

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