GCP Clinical Junior Auditor

6 days left

Location
Rockville, MD
Posted
May 26, 2017
Closes
Jun 03, 2017
Function
Audit and Tax
Industry
Science
Hours
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 GCP Clinical Junior Auditor in our Rockville, MD office to support all phases of clinical trials.

The GCP Clinical Junior 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. This individual will work closely with the QA Specialist and the QA Manager in support of Emmes’ corporate Quality Assurance Department.

Primary Responsibilities

  • Work closely with the QA Associate and the Quality Management Representative in support of Emmes's corporate Quality Assurance Department
  • Support / lead quality and standardization initiatives
  • Conducts audits to identify non-compliance to SOPs, regulations, and GCPs
  • Review Quality Records for accuracy and compliance (Compliance with SOPs, training records, test plans/scripts, CAPAs, audit reports)
  • Support regulatory/client audits
  • Assist in preparation of Quality Management Reports

Requirements

  • BS degree with at least 1 year of experience in clinical trial auditing and quality assurance
  • Certified Quality Auditor, ISO, CCRA, or equivalent certification preferred
  • 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

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

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EMMES is proud to be an Equal Opportunity Employer EOE/M/F/D/V