SeattleRecruiter Since 2001
the smart solution for Seattle jobs

Director, Clinical Research Quality and Regulatory Support

Company: Seattle Children's Hospital
Location: Seattle
Posted on: November 26, 2022

Job Description:

Accountable for providing strategic direction and leadership to the Seattle Childrens Research Institute in quality analysis and regulatory support for clinical research. Leads overall business planning and direction, contributing current knowledge and future vision of quality management to set QA policies and standards that support the achievement of high-quality clinical research for our patients and families. Responsible for establishing and maintaining a quality assurance and regulatory support program throughout the research enterprise. Responsible for directing, developing, and coordinating staff education that will continue to build and reinforce quality. This position will be the business owner for the electronic regulatory binder system, and its maintenance of part 11 compliance.Required Education/Experience:

  • Bachelors degree.
  • At least 7 years of regulatory experience.
  • Minimum 5-10 years of progressive responsibility leading the development of total quality/process improvement programs in a research/healthcare environment.
  • Demonstrated successful experience leading growth and development of QA operations, including budgetary accountability. Preferred:
    • Masters degree in a research or administration field.
    • Demonstrated knowledge of GCP and part 11 validation and compliance.
    • Recognized certification in Quality Assurance or Regulatory Affairs.
    • Proven audit experience in GCP.Hope. Care. Cure. These three simple words capture what we do at Seattle Childrens to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECUREAs one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. Researchers work in close collaboration with one another, their colleagues at partner institutions including the University of Washington and Fred Hutch and our healthcare providers at Seattle Children's Hospital, one of U.S. News & World Reports top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.Seattle Childrens requires that all employees be fully vaccinated against COVID-19. All offers are contingent and your vaccine status will be verified at onboarding.Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity,diversity, and inclusion at all levels.Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.External Job Title: Director, Clinical Research Quality and Regulatory Support Job ID / Requisition Number: 2022-46995 FTE/Hours per pay period: 1.0 FTE (80 hours per bi-weekly pay periods) Name: Research Integration Hub Shift: Day Shift Street: 818 Stewart Street Remote Work Percent: 060 Hot Job: No Our Commitment to Diversity: Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with ourincreasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin,gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran,status as an individual with a disability, or other applicable legally protected characteristics.The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity,diversity, and inclusion at all levels.Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.

Keywords: Seattle Children's Hospital, Seattle , Director, Clinical Research Quality and Regulatory Support, Executive , Seattle, Washington

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Washington jobs by following @recnetWA on Twitter!

Seattle RSS job feeds