Polly Goodman

Experience

1. Associate Director of Regulatory Affairs Operations, Smart Irb

   Harvard Catalyst The Harvard Clinical And Translational Science Center

   Sep 2019 — Present · Boston, MA, US

   Evaluate and build relationships with over institutions including the on-boarding of over 300 new institutions signing onto the SMART IRB Agreement- Advise research teams and IRB/Human Research Protections staff on the SMART IRB platforms, SMART IRB resources and provide regulatory guidance related to the implementation of Single IRB review- Design and deliver trainings sessions, materials and communications on Single IRB review and SMART IRB resources and systems for IRB/Human Research Protections staff, IRB members, investigators, research staff and SMART IRB Ambassadors- Evaluate and oversee updates of two online platforms to ensure compliance with human subject regulations and IRB processes- Collaborate with legal counsel and leadership to strategize and implement necessary changes to the existing SMART IRB reliance agreement- Oversee and support team meetings and project, including monitoring project milestones, analysis of metrics and reporting of results.

Education

• University of Vermont

  B.S., Elementary Education

  1998 — 2002

Skills

• Clinical Trials
• Microsoft Office
• Healthcare
• Regulatory Affairs
• Databases
• Clinical Research
• Ms Office Suite
• Research
• Livelink
• Irb
• Data Analysis
• Crystal Reports