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. EDUCATION REQUIREMENTS:
Bachelor's degree or equivalent experience
CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:
Lean Six Sigma Green Belt required; Lean Six Sigma Black Belt preferred
Certified IRB Professional (CIP) preferred
QUALIFICATIONS/EXPERIENCE:
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
ESSENTIAL DUTIES/RESPONSIBILITIES:
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
ABOUT US: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.