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Director, IRB Affairs

Western IRB


Location:
Puyallup, Washington 98374
Date:
06/19/2017
2017-06-192017-07-19
Job Code:
17099
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Regulatory Affairs
  • Business Development/Operations
  • Medical Affairs
Western IRB
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Job Details

For more than 45 years, Western Institutional Review Board® (WIRB), a member of the WIRB-Copernicus Group, 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, WIRB 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 distinguished staff of full-time physicians, Certified IRB Professionals, lawyers, and research professionals delivers unparalleled review quality to ensure that human research studies withstand scrutiny around the world.

Our Director of IRB Affairs will be reasonable to lead the daily activities of the expedited review team.  The Director of IRB Affairs will be responsible for the continuous improvement of expedited reviews through process improvement, leveraging technology, engaging a talented workforce and leading change initiatives to meet and exceed objectives while contributing to the company’s overall mission to protect the rights and welfare of human subjects involved in research. Will also have direct report relationship with Manager, IRB Affairs and ensure team is engaged and delivering on performance goals and expectations.

Essential Duties and Responsibilities  

  • Responsible for the strategic and day to day leadership of the expedited team and the Manager of IRB Affairs
  • Perform all duties of a Board member and the duties of an Expedited Reviewer
    • Oversee and administer the workflow queues ensuring that quality and turn-around time (TAT) expectations are met
  • Facilitate the delivery of a customer focused, cost effective and continuously improving products and services
  • Lead cross-functional initiatives in support of expedited service offering expansion
  • Provide superior customer service to all clients with inquiries, issues or needs. Lead the expedited teams toward technological advancing methods of processing study related information and communicating with clients 
  • Establish and implement processes and metrics to ensure client expectations are upheld
  • Partner with other departments to develop efficient processes while upholding regulatory requirements
  • Monitor department metrics and utilize data to increase productivity and service. 
  • Stay abreast of changes in FDA and OHRP regulations and company-wide processes so as to be a reliable resource to staff and clients
  • Must maintain confidentiality in all matters and handle all matters discretely

Requirements

Education Requirements

  • Bachelor’s degree from a four-year college or university.
  • A degree or background in nursing or related field is a plus

Essential Qualifications:

  • A minimum of three years of experience in a medical or healthcare related field 
  • A minimum of three years of experience in a leadership role 
  • Experience in chairing Board meetings with strong leadership presence is preferred
  • Excellent attention to detail and creative problem solving abilities
  • Proven record of working well under pressure on concurrent, multidisciplinary projects.
  • Basic understanding of medical terminology, diseases and their causes, and standard treatments for the more common diseases is preferred
  • Client Centric - track record for understanding Products/Services and Customer needs
  • Must be willing to learn guidelines and requirements of applicable Regulatory agencies, Federal Drug Administration (FDA) and the Office for Human Research Protections (OHRP)
  • Provide clear and consistent performance expectations and support to meet goals.  Checks on progress and provides coaching where needed 
  • Collaborative – reaches out to others to build relationships, explore cross function opportunities for operational excellence
  • Result oriented and does what is necessary to improve performance
  • Identifies and acts on opportunities for process improvements and skills in change management
  • Self-motivated and assumes ownership of and accountability for assignments and responsibilities and holds others accountable
  • Thought Leader - creativity to take the business to the next level

Certifications/License/Registration Requirements:

  • Must commit to passing the CIP exam within 2 years of reaching the minimum qualification of 2 years with an IRB.  Maintain CIP certification once obtained

SUPERVISORY RESPONSIBILITIES:  Overall responsibility of management including direction, coordination, performance, and evaluation of the assigned team and staff. Responsibilities include training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

TRAVEL REQUIREMENTS:  Occasional travel may be required