ClinOps (Clinical Operations)

Clinical Operations refer to the activities that support the clinical trial process from start-up to close out. Clinical Operation professionals are tasked with the planning, implementation, management, and execution of the clinical trial process.

Clinical Operations involve a broad range of activities to ensure timely execution and adherence to human subject regulations and policies of Good Clinical Practice:

 

  • Development of protocol and other study documents.
  • Identification of clinical trial sites and investigators.
  • Training, startup, and management of clinical sites.
  • Managing logistics of study materials.
  • Providing a channel of communication between research teams specializing in clinical science, statistics, pharmacovigilance, data science, regulatory activities, legal, and marketing, while keeping them up to date and on task.
  • Fiscal management.
  • Identifying project risks and planning for changes ahead of time.
  • Internal and external stakeholder management.
  • Quality management.
  • Trial closeout and reporting.

 

Clinical operation roles include Clinical Operations Directors, Project Managers, Clinical Trial Managers, Clinical Research Associates/ Trial Monitors, and Clinical Trial Assistants.

Source: Cramer, G. (2020, March 10). Assessing the Operational Complexity of a Clinical Trial: The Experience of the National Institute of Mental Health. ACRP. Retrieved January 25, 2022, from https://acrpnet.org/2020/03/10/assessing-the-operational-complexity-of-a-clinical-trial-the-experience-of-the-national-institute-of-mental-health/