Clinical Operations

Smilow Center for Translational Research

Our Mission:

To manage and optimize the clinical research infrastructure necessary for bringing novel/personalized cell and gene therapies to patients. 

Key Objectives:

  • Support the translation of first-in-human investigational cell and gene therapy products from the bench to bedside.
  • Manage/accelerate the clinical trial development and new study activation pathways.
  • Establish internal and external collaborative partnerships.
  • Establish/maintain the infrastructure required to standardize and optimize clinical trial development and execution; and ensure ongoing oversight/compliance.
  • Develop/refine standardized processes, procedures, and templates/tools to align with the changing regulatory landscape and new scientific innovation.
  • Ensure generation of high-quality, reliable and statistically sound clinical data that can be used for reporting, publication, endpoint analysis and further product development.
  • Identify/implement new technology/systems required to enhance clinical research operations.

Core Responsibilities

Clinical Development:

  • Manage the clinical trial development and study activation pathway
  • Establish and maintain core document templates
  • Facilitate new protocol and other core document development
  • Develop and implement protocol/core document amendments

Project Management

  • Overall project implementation
  • Establish the required infrastructure for executing new clinical trials
  • Work with collaborative partners to manage study operations/study conduct
  • Site Management: Establish/maintain project timelines, develop/perform study training, develop/maintain operational manuals, DSMB coordination/management, ensure timely data collection/reporting, etc.
  • Document Management: Establish and maintain the Sponsor Trial Master File (TMF)

Data Management:

  • Database development and ongoing maintenance activities
  • Perform data management review/cleaning
  • Ensure overall data completeness and quality/integrity
  • Facilitate data reporting/archiving