The People Around You, and Who Does What

Part of Research Assistant (ASSIST) Training: What This Job Is, and What It Is Not.

About 2 minutes. Free, in your language, no account needed.

A small team with clear lines

The principal investigator, usually a doctor, is responsible for the whole study at your site. They make the medical decisions.

Sub-investigators are other doctors or clinicians who can do specific medical tasks the principal investigator has formally given them.

The study coordinator runs the day to day. Scheduling, consent paperwork, data entry, keeping the study on track. This is usually who you report to.

The research nurse does clinical things to participants: observations, samples, administering treatment.

The monitor visits from outside. They work for the company sponsoring the study and they check that the site is following the protocol and that the records match what happened.

The pharmacist looks after the investigational product.

The delegation log

There is a document at every site listing each person and the specific tasks they are allowed to do. It is signed by the principal investigator.

If a task is not next to your name, you do not do it. Not because someone is being strict, but because the log is the evidence that qualified people did the work. A task performed by someone not delegated for it is a finding, and the result can be thrown out.

Ask to see the log, and ask which lines are yours. It is a completely normal thing for a new person to ask.

The monitor is not there to catch you

New staff often find monitoring visits stressful. A monitor is checking the records, not judging you personally. If they find something wrong, the useful response is to help them understand what happened.

Never change a record to make a visit go more smoothly. That turns a small correctable error into a serious one.