Coord, QA & Compliance

Duke Health | Durham, NC, United States

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Posted Date 1/22/2024
Description School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Assist the Duke Animal Care and Use Program, Office of Animal Welfare Assurance to ensure data integrity, compliance with federal and state regulations, and compliance with funding, oversight, and local/institutional requirements pertaining to but not limited to laboratory animal care and use. Perform a variety of duties associated with the offices Quality Assurance Program to include the collection and analysis of data, the development of policies and procedures, and the orientation and training of departmental staff in quality assurance policies and procedures.

Hybrid on-site and remote, telecommuting work schedule available.

Work Performed

  • IACUC/OAWA Refinement and IT Solutions Lead (50%)
    • Help develop, implement, train, support, and maintain all information technology (IT) solutions within OAWA, including day-to-day interactions with OIT/OASIS/etc. and be a liaison to the IT solutions leads in DLAR. This includes making operational and programmatic decisions related to protocol/amendment review processes to ensure successful achievement of OAWA requirements, objectives, and regulatory, granting, and external oversight requirements.
    • Help develop, coordinating implementation, and advise/train staff on the program process.
    • Maintain the IT solution once implemented to ensure it meets ever-changing compliance requirements within and external to Duke, trouble-shooting issues, monitoring and evaluating effectiveness, evaluate concerns and track trends, implement refinements to improve effectiveness and efficiency, and assist research and support personnel in understanding/using the solution, etc.
    • Help develop, explore, implement, train, and support refinements to submission, review, and documentation processes within OAWA that may or may-not have an IT solution.
    • Support the OAWA Director in program internal and external program reviews as they related to this item.
  • Management of Institutional Animal Care and Use Committee (IACUC) and Office of Animal Welfare Assurance (OAWA) document processing (10%). This includes, but is not limited to:
    • Make operational and programmatic decisions to ensure institutional regulatory and oversight responsibly are being implemented and accomplished.
    • Monitor and evaluate document processing effectiveness using a data-driven approach to ensure internally established policies and SOPs are being adhered to ensure appropriate documentation.
    • Review of initial document submission, distribution to reviewers, assisting reviewers and researchers, documentation, additional document processing, generating and sending follow up-letters, reminders, and outcome letters as required according to existing IACUC-reviewed and approved policies and OAWA SOPs.
    • Review and approval amendments that can be handled administratively according to existing IACUC-reviewed and approved policies and OAWA SOPs.
    • Monitor deadlines and expirations. Communicate with appropriate individuals as necessary.
    • Work with departments to ensure their individual needs related to IACUC protocols is accomplished.
    • Work to expand, refine, and/or replace existing program components. Including but not limited to:
      • IACUC protocol form refinements
      • IACUC protocol/document processing refinements
      • Record keeping, tracking, and notification processes
  • Provide support to the Duke Animal Program, IACUC, and Office of Animal Welfare Assurance (OAWA) (5%):
    • Review and implement internal controls, policies, and procedures to ensure compliance with appropriate University, State, and Federal guidelines and policies, sound animal use practices, and overall Program goals and objectives.
    • Respond promptly to external and internal concerns; implementing corrective actions as appropriate.
    • Monitor deadlines and expirations. Communicate with appropriate individuals as necessary.
    • Contribute to external outreach and training initiatives of the IACUC/OAWA, to include but not limited to: Brown Bag Seminars, Animal Track Newsletters, and the Research Animal Coordinator Certification program.
    • Serve as a liaison and/or provide customer service with other critical components of the Duke Animal Care and Use Program to ensure cooperative efforts are enhanced and available resources are utilized (e.g., OAWA Compliance Liaisons, OAWA Director, OAWA Office Manager, the Division of Laboratory Animal Resources, the Duke Lemur Center, the Duke research community, etc.)
    • Other duties may include, but are not limited to: research training participation and verification, additional recordkeeping, grant congruency reviews, ad-hock facility inspector, and other administrative duties.
  • Supervise OAWA Compliance Specialist (10%):
    • Oversee and supervise the Compliance Specialist team to ensure all required job functions are complete and accurate to include developing and implementing procedures, processes, services and/or systems to accomplish requirements and goals.
    • Train Protocol Specialist team in proper methods and procedures to ensure correctness of work.
    • Provide staff leadership. Recommend various personnel actions including, but not limited to, hiring, performance appraisal, promotions, transfers and vacations schedules.
  • Perform other related duties incidental to the work described herein. Percent effort may vary based on need.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Qualifications at this Level

Education/Training: Work requires a bachelor's degree in a science or related field to acquire the appropriate cognitive, communicative and statistical reporting skills.

Experience: Work requires three years of experience in animal program administration or involving academic, instructional or counseling activities to acquire skills necessary to plan, coordinate and implement a variety of program activities and events. This may include experience in an animal related field that oversees animal care and/or laboratory-animal or client-animal interactions and involves providing instruction or counseling to animal owners or researchers (e.g., public or private university animal program, animal hospital or veterinary clinic, or other animal entity). Experience in clinical laboratory analysis, clinical laboratory quality assurance, or related position also considered.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills:

  • Ability to provide guidance and direction to subordinates, including setting standards and monitoring performance.
  • Skills using logic and reasoning to identify the strengths and weaknesses of alternative solutions to problems.
  • Skills evaluating program performance, summarizing findings, communicating results, and forming an action plan.
  • Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, and coordination of people and resources.
  • Experience with MS Access, Adobe, and Excel perferred.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring dep

Minimum Qualifications

Education

Work requires a bachelor's degree in a science or related field to acquire the appropriate cognitive, communicative and statistical reporting skills.

Experience

Work requires two years of experience in clinical laboratory analysis, OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE clinical laboratory quality assurance or related position. A related master's degree may offset years of experience on a 1:1 basis.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Category
Healthcare & Public Health | QA-Quality Control

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