Clinical Operations

  • location: Northbrook, IL
  • type: Contract
  • salary: $80 - $85 per hour

job description

Clinical Operations

Chat with me now! - https://flashrecruit.com/jobs/301527

Job Title: Clinical Compliance Resource I

Position Description

  • Provide compliance oversight, consultation services and compliance advice to the Medical and Development organizations
Position Responsibilities

  • Together with M&D will identify areas of highest potential compliance risk across Medical and Development programs
  • Clinical Investigator Site Audits of Phase 3b/4 studies
  • Clinical QA will provide core training in GCP, the Quality Management System and the audit process
  • Provide inspection training and support for potential inspections by regulatory authorities
Position Requirements

  • Bachelor's degree
  • Minimum of 3 years in pharmaceutical, biotechnology, or related industry
  • Minimum of 1 year significant experience in Clinical Quality Assurance (except for Japan

    internal candidates)
  • Minimum of 2 years project management/clinical monitoring experience, preferably in a highly

    matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and

    conflict resolution skills
  • In-depth understanding of GCP requirements for both marketed and investigational products
  • Practical experience and understanding of clinical quality assurance as applied throughout

    the entire pharmaceutical compound/product life cycle
  • Effective oral and written communication and presentation skills in English and/or Japanese
  • Solid understanding of CRQA processes
  • Proficiency in Microsoft Office.
  • Domestic and international travel at 10-25% as required.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Chat with me now! - https://flashrecruit.com/jobs/301527

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