Clinical Research Quality Assurance Auditor

Rockville, MD
Mar 15, 2017
Mar 31, 2017
Full Time

The Emmes Corporation, founded in 1977, is a successful contract research organization based in Rockville, Maryland, dedicated to the support of medical research with a public health impact. Emmes is seeking a Clinical Research Quality Assurance Auditor in our Rockville, MD office to support all phases of clinical trials.

The Clinical Research Quality Assurance Auditor will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of Emmes projects, department, processes, and vendors used to support clinical trials. He/she will be responsible for assisting in various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs, and applicable regulations. This individual will work closely with the Quality Assurance Manager in support of Emmes’ corporate Quality Assurance Department.

Primary Responsibilities

  • Provide GCP/QA consultation to Emmes staff
  • Support / lead quality and standardization initiatives
  • Drive completion of quality compliance plans
  • Conducts audits to identify non-compliance to SOPs, regulations, and GCPs
  • Write/revise SOPs, as needed
  • Assist in the management of the CAPA program
  • Review Quality Records for accuracy and compliance (Compliance with SOPs, training records, test plans/scripts, CAPAs, audit reports)
  • Support supplier/vendor qualification and evaluation
  • Support Change Control Board quality system/validation representation
  • Support regulatory/client audits
  • Assist in preparation of Quality Management Reports


  • BS degree in science-related field preferred, or equivalent years of experience in clinical trial auditing and quality assurance
  • Certified Quality Auditor, ISO, CCRA, or equivalent certification preferred
  • An in-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (eg, ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies
  • Experience in GCP auditing activities
  • Thorough knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines
  • Strong written and oral communication skills
  • Ability to work with others as well as independently
  • Ability to multi-task
  • Excellent organizational skills
  • Enjoy working in a team environment

For immediate consideration please apply though the link below-;jsessionid=6034F1E421183BCF81A7A0AC17390D45?org=EMMES&cws=1&rid=1597

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