What are the responsibilities and job description for the Compliance and Quality Specialist I/II position at Seattle Children's?
*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 Children’s. 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 high-quality 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 close-out.
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 institute-level 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 system-wide compliance-related oversight initiatives (e.g., training tracking and compliance, ct.gov 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*
Bachelor’s 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 cross-functional teams, including data collection, analysis, and reporting.
Proven record of project completion, program planning, execution, and status reporting.
Experience leading committees, activities, and staff.
*Level II*
Bachelor’s 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 cross-functional teams, including data collection, analysis, and reporting.
Proven record of project completion, program planning, execution, and status reporting.
Demonstrated experience in leading multi-disciplinary 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 care-related 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*
$95,270.00 - $157,195.00 per year*Salary Information*
This compensation range was calculated based on full-time 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 Children’s 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.org/careers/benefits](https://www.seattlechildrens.org/careers/benefits).
*About Us*
*Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – 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? #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 children’s hospital in the country.
In 2022, U.S. News & World Report once again ranked Seattle Children’s among the nation’s best children’s hospitals – for the 30th year in a row. For more than a decade, Seattle Children’s has been nationally ranked in all 10 specialty areas evaluated by U.S. News & World Report. We are honored to be the top-ranked pediatric hospital in Washington and the Pacific Northwest.
As a Magnet designated institution, and classified among America’s best large employers by Forbes, we recognize the importance of hiring and developing great talent to provide best-in-class 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 it’s 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 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.
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 Children’s. 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 high-quality 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 close-out.
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 institute-level 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 system-wide compliance-related oversight initiatives (e.g., training tracking and compliance, ct.gov 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*
Bachelor’s 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 cross-functional teams, including data collection, analysis, and reporting.
Proven record of project completion, program planning, execution, and status reporting.
Experience leading committees, activities, and staff.
*Level II*
Bachelor’s 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 cross-functional teams, including data collection, analysis, and reporting.
Proven record of project completion, program planning, execution, and status reporting.
Demonstrated experience in leading multi-disciplinary 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 care-related 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*
$95,270.00 - $157,195.00 per year*Salary Information*
This compensation range was calculated based on full-time 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 Children’s 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.org/careers/benefits](https://www.seattlechildrens.org/careers/benefits).
*About Us*
*Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – 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? #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 children’s hospital in the country.
In 2022, U.S. News & World Report once again ranked Seattle Children’s among the nation’s best children’s hospitals – for the 30th year in a row. For more than a decade, Seattle Children’s has been nationally ranked in all 10 specialty areas evaluated by U.S. News & World Report. We are honored to be the top-ranked pediatric hospital in Washington and the Pacific Northwest.
As a Magnet designated institution, and classified among America’s best large employers by Forbes, we recognize the importance of hiring and developing great talent to provide best-in-class 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 it’s 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 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.
Salary : $95,270 - $157,195
