Clinical Research Operations

Responsibilities of the Research Team

A successful clinical trial program is typically comprised of a team of individuals who are committed to conducting high-quality clinical trials. All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. All research teams are led by a Principal Investigator (PI) and have research participants. Other key staff include, but are not limited to: Nurses, Study Coordinators, and Clinical Data Managers. This module will provide an overview of key roles of the research team. The module is divided into 3 required components (videos) and 3 recommended videos. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records. 

Module Objectives
At the conclusion of this module, learners will be able to:

• Describe the role and responsibilities of the Investigator as described by OHRP, FDA, and ICH GCP.                                                                             

• Describe the role and responsibilities of the Research Nurse.

• Describe the role and responsibilities of the Study Coordinator.                 

• Describe the role and responsibilities of the Clinical Data Manager.

• Describe the role and responsibilities of the pharmacist.