Experience

National Center for Advancing Translational Sciences (NCATS)

• United States
• Research
• 200 - 300 Employee

• Acting Director, Office of Translational Medicine

  • Oct 2021 - Present

• Senior Adviser for Clinical Research

  • Nov 2017 - Present

  Bethesda, MD Demonstrated subject matter expert in Human Subjects Protections Reglations, Policies, Guidance, Procedures and Science to inform leadership about clinical research policies and related issues. Valued consultant for Human Research Protections issues for NIH. Responsible for implementation of NIH single IRB Policy for NCATS Clinical and Translational Science Awards (CTSA) Program. Communicates effectively in writing and orally in scientific program areas to NIH, NCATS… Show more Demonstrated subject matter expert in Human Subjects Protections Reglations, Policies, Guidance, Procedures and Science to inform leadership about clinical research policies and related issues. Valued consultant for Human Research Protections issues for NIH. Responsible for implementation of NIH single IRB Policy for NCATS Clinical and Translational Science Awards (CTSA) Program. Communicates effectively in writing and orally in scientific program areas to NIH, NCATS leadership and staff, the public, media, and other stakeholders



Office of the Assistant Secretary of Health

• Detailee, OHRP Division of Policy and Assurances

  • Feb 2021 - Present

  United States Consults on development of guidance for implementation of the revised Common Rule.



Office of Science Policy, NIH

• Director, Clinical Research Policy

  • Mar 2011 - Nov 2017

  Office of the Director, NIH Developed trans-agency initiatives and participated on priority projects for the Department of Health and Human Services related to facilitating clinical research, enhancing clinical trials, and enhancing human research protections. Liaison to DHHS Office for Human Research Protections for policies, guidance, and compliance activities.



National Institute of Biomedical Imaging and Bioengineering (NIBIB)

• Director, Office of Extramural Policy

  • Feb 2007 - Feb 2012

  Office of Research Administration, NIBIB Developed and implemented extramural policies for human subjects protections, animal welfare concerns, inclusion of women, minorities, and children in NIBIB-supported research, research integrity, conflict of interest, and other policies related to Program and Review, and Grants Management. Conducted training for NIBIB staff.



The National Institutes of Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Human Subjects Protections Program

  • 2000 - 2008

  Office of Extramural Programs, Office of Extramural Research Responsible for ensuring that protections for human research participants were appropriate for the NIH. Conducted training for NIH staff and the research community. Served as liaison between NIH and other Federal offices, scientific organizations, and professional societies. Developed implementation policies and guidance related to human research protections.

• Extramural Research Integrity Liaison Officer

  • 2000 - 2007

  Office of Extramural Programs, Office of Extramural Research Liaison between the NIH Agency Research Integrity Liaison Officer, Agency Extramural Research Integrity Officer, and IC Research Integrity Officers (RIO), NIH-funded institutions, and the DHHS Office of Research Integrity (ORI). Conducts pre-inquiry assessments of allegations of research misconduct, requested formal institutional inquiries and investigations into misconduct allegations, and monitored inquiries and investigations. Developed policies for NIH Extramural staff on handling… Show more Liaison between the NIH Agency Research Integrity Liaison Officer, Agency Extramural Research Integrity Officer, and IC Research Integrity Officers (RIO), NIH-funded institutions, and the DHHS Office of Research Integrity (ORI). Conducts pre-inquiry assessments of allegations of research misconduct, requested formal institutional inquiries and investigations into misconduct allegations, and monitored inquiries and investigations. Developed policies for NIH Extramural staff on handling allegations of research misconduct, recovery of unallowable costs after research misconduct, and for handling violations of the NIH peer review process.



NIH

• Biosafety Officer

  • 1997 - 2000

  ORS Served as a Biosafety Officer, Quarantine Permit Service Officer, and Alternate Responsible Official for Select Agents for the NIH Intramural Program. She was also Vice-Chair of the VRP Animal Care and Use Committee and a member of the Clinical Center Bioethics Committee.



The National Institutes of Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Staff Fellow, Laboratory of Microbial Pathogenesis, NIDR

  • 1992 - 1996

  National Institute of Dental Research Conducted research in microbial pathogenesis, investigating the activation of bacterial toxins by mammalian cells.



USUHS

• Research Services
• 300 - 400 Employee

• Post-Doctoral Fellow, Department of Microbiology

  • 1989 - 1992

  Department of Microbiology Conducted research on Shiga-like toxins and was a co-inventor on a patent for a vaccine to prevent edema disease of swine.