Senior Protocol Specialist

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care 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 ex