Clinical Research QA Specialist

Location
Rockville, MD
Posted
May 23, 2017
Closes
May 31, 2017
Industry
Research
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 Clinical Research QA Specialist in our Rockville, MD office to support all phases of clinical trials.

The Clinical Research QA Specialist 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

  • Conduct internal audits to identify non-compliance in adherence to SOPs, regulations and GCPs
  • Work closely with the QA Associate and the QA Manager in support of Emmes's corporate Quality Assurance Department
  • Support quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs, applicable regulations and promote quality
  • Provide GCP/QA consultation to Emmes staff
  • Support / lead quality and standardization initiatives
  • Drive completion of quality compliance plans
  • Write/revise SOPs, as needed
  • Lead management of the CAPA program
  • Support supplier/vendor qualification and evaluation
  • Support Change Control Board quality system/validation representaiton
  • Support regulatory/client audits
  • Prepare Quality Management Reports
  • Drive completion of quality compliance plans

Requirements

  • BS degree in science-related field preferred, and at least 5 year of experience in clinical trial QA and auditing experience
  • 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

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