Compliance and Quality Specialist III
Compliance and Quality Specialist III
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$ 95270 - 157195
1 Vacancy
Job Description
General Functions
The Compliance and Quality Specialist is an integral member of the Office of Research Compliance (ORC) and reports directly to the Director Office of Research Compliance. The Compliance and Quality Specialist will work as part of the ORC team to help support and facilitate compliance in all aspects of clinical research and ensure quality for select manufacturing operations at Seattle Childrens. This position is a key quality and compliance advisor for clinical research and manufacturing operations. The individual will work with team members to facilitate and conduct highquality compliance reviews which include review preparation conduct close out and reporting to ensure compliance with federal regulations and institutional policies. This position will interface with research investigators and staff throughout the review process. Within the ORC the Compliance Specialist will interface with other ORC staff to ensure the best support of research regulatory requirements to assist with ORC research educational initiatives and to participate in research staff training.
Job Responsibilities
Assist in facilitating and conducting compliance reviews for assigned Investigators Sponsors or other clinical research topics as necessary including preparation reporting and closeout.
Assist in the conduct of training of Investigators Sponsors and Clinical Research Staff in areas related to clinical research and manufacturing compliance.
Author review and revise the institutelevel Compliance and/or Quality Systems procedures and policies.
Oversee all quality systems to ensure ongoing GMP and GCP compliance.
Support other ORC initiatives as needed.
Assist in other systemwide compliancerelated oversight initiatives (e.g. training tracking and compliance ct tracking and compliance institutional conflict of interest compliance).
This is a hybrid remote position and must be based in Washington state.
Required Education and Experience
Level I
Bachelors Degree in business health care or related field or equivalent combination of education and experience.
Three 3 years of experience in a lead role overseeing program/project management.
Three 3 years of experience working on quality and process improvement projects with crossfunctional teams including data collection analysis and reporting.
Proven record of project completion program planning and status reporting.
Experience leading committees activities and staff.
Level II
Bachelors Degree in business health care or related field or equivalent combination of education and experience.
Five 5 years of experience in a lead role overseeing program/project management.
Four 4 years of experience working on quality and process improvement projects with crossfunctional teams including data collection analysis and reporting.
Proven record of project completion program planning and status reporting.
Demonstrated experience in leading multidisciplinary teams committees activities and staff.
Required Credentials
N/A.
Preferred
Level I
Experience working in public health health care or social services.
Project Management Professional (PMP) Certification.
Experience analyzing improvement data and working with internal clients to analyze and develop improvement strategies.
Experience in project managing large complex organizational initiatives that cross all departments and roles
Level II
Masters in Health Administration business or health carerelated field.
Project Management Professional (PMP) Certification.
Demonstrated ability to lead improvement efforts related to strategic goals.
Experience working in public health health care or social services.
Compensation Range
$95270.00 $157195.00 per yearSalary Information
This compensation range was calculated based on fulltime employment 2080 hours worked per calendar year). Offers are determined by multiple factors including equity skills experience and expertise and may vary within the range provided.
Disclaimer for Out of State Applicants
This compensation range is specific to Seattle positions located outside of Seattle may be compensated differently depending on various factors.
Benefits Information
Seattle Childrens offers a generous benefit package including medical dental and vision plans 403(b) life insurance paid time off tuition reimbursement and more. Additional details on our benefits can be found on our website www.seattlechildrens/careers/benefits.
About Us
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 missiondriven organization that is lifechanging to many and touches the hearts of all #HOPECARECURE
Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region regardless of the families ability to pay. Together we deliver superior patient care advance new discoveries and treatments through pediatric research and serve as the pediatric and adolescent academic medical center for Washington Alaska Montana and Idaho the largest region of any childrens hospital in the country.
In 2022 U.S. News & World Report once again ranked Seattle Childrens among the nations best childrens hospitals for the 30th year in a row. For more than a decade Seattle Childrens has been nationally ranked in all 10 specialty areas evaluated by U.S. News & World Report. We are honored to be the topranked pediatric hospital in Washington and the Pacific Northwest.
As a Magnet designated institution and classified among Americas best large employers by Forbes we recognize the importance of hiring and developing great talent to provide bestinclass care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion Excellence Integrity Collaboration Equity and Innovation. Whether its delivering frontline care to our patients in a kind and caring manner practicing the highest standards of quality and safety or being relentlessly curious as we work towards eradicating childhood diseases these values are the fabric of our culture and community. The future starts here.
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 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 Childrens 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 Childrens is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
