Current Environment:

Clinical Research Operations Core | Overview

The clinical research professionals of the Clinical Research Operations Core provide exceptional support and service to investigators conducting clinical research studies at Boston Children’s Hospital. The core supports a full spectrum of studies from high-risk interventional trials with experimental therapeutics, and experimental drugs and devices, to the minimal-risk observational clinical research studies. The core provides exceptional service in the following areas:

  • protocol development
  • project management for planning and implementation of studies
  • case report form creation
  • coordination of database builds
  • recruitment and retention of research subjects
  • administration of surveys, interviews and study tracking
  • biospecimen collection and tracking
  • medical record abstraction, data entry and reports
  • study close out activities management of multi-institutional clinical trials
  • single patient INDs
  • support for FDA-regulated trials
  • development of data safety monitoring plans and data safety monitoring boards or committees
  • facilitating collaborative partnerships among key institutional resources that support clinical research
  • foster collaborative relationships between clinical trialists and basic/translational researchers
  • support for grant applications and publication submissions
  • medical writing
  • scientific review
  • support for consortium work

For more information or to request assistance, contact Leah Cheng