General Information

Location: Cary, NC, Puyallup, WA

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements

The Client Insights and Quality Control Specialist will oversee process consistency through the review of documents generated to effectively decrease the company error rate, improve operational efficiency and customer satisfaction.  They will maintain the highest level of quality through implementation of business process improvements.

  • Bachelor’s degree or equivalent experience

  • Lean Six Sigma Green Belt preferred
    • Green belt would be required to be completed within first 12 months of employment
  • Certified IRB Professional (CIP) preferred  

  • Minimum 2 years’ experience in IRB or clinical research setting with evidence of increasing responsibility 
  • Knowledge of relevant FDA Code of Federal Regulations 
  • Must have advanced knowledge in Microsoft Outlook, Word, Excel, and other reporting software used by the company
  • Meeting deadlines, working in multi-tasking situations, and working independently is required 
  • Must have excellent attention to detail and the ability to effectively communicate errors and suggestions for improvement to the appropriate staff 
  • Strong interpersonal skills such as a focus on problem solving, negotiating, listening objectively and openly to others’ ideas, and contributing to building a positive team spirit  
  • Ability to engage and motivate staff

  • Review the quality of the company’s process and documents generated to effectively decrease the company error rate and improve operational efficiency and customer satisfaction in accordance with company standards
  • Review operational errors as reported by customers and the company and utilize lean six sigma tools to:
    • Determine which errors should be prioritized for improvement 
    • Lead root cause problem solving analysis
    • Implement improvements to the process 
    • Create reports to trend errors and measure improvements
  • Maintain working knowledge of operational processes and changes
  • Communicate clear and professional feedback/information to all departments in the company where appropriate
  • Maintain and promote positive working relationships with the interrelated departments by providing timely and professional service to their needs within the scope of the company mission
  • Research inquiries and issues that relate to corrections and identify any training trends
  • Quality check study files to ensure accuracy and adherence to file structure
  • Conduct job shadowing to identify efficiencies and propose solutions
  • Act as a Change Agent to grow culture
  • Maintain proficiency in all electronic systems, including Connexus, and provide training to staff and clients, as needed 
  • Stay abreast of applicable federal regulations governing IRB review of research by attending seminars and training sessions, as required
  • Actively participate in process improvement to create efficient methods of all processes within the company
  • Oversee operational improvements and ensure changes are implemented as agreed upon by stakeholders and in a timely manner
  • Implement statistical methods to monitor and control process quality
  • Assure that all processes and systems meet the quality requirements of clients
  • Ensure gaps in quality are addressed with appropriate corrective action, in conjunction with Operations’ staff and Quality Management
  • Represent operational staff in IT/IM efforts related to the development and implementation of business systems, including but not limited to requirements planning and user acceptance testing
  • Must maintain confidentiality in all matters and handle all matters discretely

For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human subjects during all phases of clinical trials.  Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.