About The Position

The Research Quality Assurance Supervisor is responsible for ensuring industry standards of quality being met and exceeded on an on-going basis. The individual will be responsible for providing advice and support to Operations staff in the implementation of, and adherence to, processes, controlled documents, tools, and templates to enhance the quality of deliverables. He/she will identify process improvement opportunities, author and review new processes. Support process re-engineering; contribute to the development of training materials as process subject matter expert. Will create a quality assurance program through which investigators and research staff involved in the conduct of clinical research will be educated and trained on current industry standards.

Requirements

  • Bachelors degree is required.
  • A minimum of 5 Years experience in clinical research experience, a strong preference for a candidate with an Oncology background.
  • Project Management or supervisory experience.
  • Strong working knowledge of CFR 21, GCP and ICH Guidelines.
  • Minimum Required Experience: 5 Years

Nice To Haves

  • SoCRA or ACRP preferred.

Responsibilities

  • Ensuring industry standards of quality being met and exceeded on an on-going basis.
  • Providing advice and support to Operations staff in the implementation of, and adherence to, processes, controlled documents, tools, and templates to enhance the quality of deliverables.
  • Identifying process improvement opportunities.
  • Authoring and reviewing new processes.
  • Supporting process re-engineering.
  • Contributing to the development of training materials as process subject matter expert.
  • Creating a quality assurance program through which investigators and research staff involved in the conduct of clinical research will be educated and trained on current industry standards.

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

5,001-10,000 employees

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