Protocol and study conduct
Reading a protocol accurately and carrying it out as written, including eligibility, visit windows and required assessments.
Informed consent
Running and documenting consent so the participant understood, and the record shows how and when that happened.
Data and source documentation
Recording work so that it is attributable, legible, contemporaneous, original and accurate, and reconciling it against the data collected.
Safety and event handling
Recognizing, classifying and escalating events within the timelines the protocol and regulation require.
Deviations and quality
Identifying what went wrong, judging what is reportable, and writing the corrective and preventive action.
Communication and documentation
Writing follow-up letters, queries and notes to file that another professional can act on without a conversation.