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 ClinicalTrials.gov 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