While the principal investigator is ultimately responsible for the conduct of a study, including the safety and welfare of any clinical research participants, tasks such as the following are commonly delegated to a research coordinator:
- Overseeing screening and enrollment activities
- Conducting the informed consent process
- Conducting study visits
- Obtaining and shipping specimens
- Completing case report forms
- Communicating with the study sponsor
In addition, other tasks that might be delegated, depending on the experience and capabilities of the individuals involved, include:
- Handling IRB submissions and correspondence
- Writing consent forms and the protocol to be followed in completing them
- Documenting eligibility of study participants
- Maintaining all regulatory documents
- Preparing adverse event forms
- Developing quality assurance and quality control measures
All delegated responsibilities should be documented in writing by the PI. Furthermore, a viable communication network should be established between the PI, the research coordinator, and any other members of the research team with delegated responsibilities.
