Principal Investigator (PI)
A Principal Investigator (or PI) is a medical researcher (and oftentimes a physician or other qualified medical professional) in charge of carrying out the research study plan (called a "protocol"). The PI is frequently referred to as the "study doctor", and is personally responsible for all medical, legal, and ethical aspects of the study as well as protecting the rights, safety, and welfare of subjects under their care.
General Responsibilities of Principal Investigators
- Ensuring that the study is conducted properly according to the research plan (protocol) as well as government and local regulations.
- Protecting the rights, safety, and welfare of subjects under principal investigator's care
- Controlling the drug or device under investigation
Clinical Research Coordinator
A Clinical Research Coordinator is a key member of the principal investigator's research team, and may be a registered nurse or other medically trained individual, although medical training is not always required. The role of the Clinical Research Coordinator may vary from study to study and is determined by the principal investigator's needs.
The Clinical Research Coordinator often organizes the study, conducts tests and procedures required for the study, completes required documentation, and serves as a liasion between the institution and the sponsor of the study (such as a pharmaceutical company).
Oftentimes, the Clinical Research Coordinator is the primary contact person for people enrolled in research studies, and will frequently interact with research subjects.
General Responsibilities of Clinical Research Coordinators
Under the guidance and supervision of the principal investigator, the duties of the Clinical Research Coordinator may include the following:
- Recruiting and screening the potential study subjects
- Obtaining proper written informed consent from each study subject prior to participation in the study
- Scheduling study subjects' visits and assisting the PI at each visit
- Maintaining records of subjects' status in the study