Clinical research coordinator (CRC)
In Roles & organizations
Also known as: study coordinator, research nurse, clinical trial coordinator
A clinical research coordinator runs the day-to-day operation of a trial at a site. The CRC schedules participant visits, takes or supports informed consent, keeps source documents, enters data, handles supplies, and is the main contact for the monitor. It is the most common first role in clinical research.
| Task | The rule behind it |
|---|---|
| Works under the investigator's delegation | The investigator may delegate trial activities, keeps overall responsibility, and keeps a record of who was delegated what (Annex 1, 2.3.1 and 2.3.3). |
| Is trained for each delegated task | Delegated staff should be qualified and adequately informed about the protocol and their activities (Annex 1, 2.3.2). |
| Supports informed consent | Informed consent is integral to an ethical trial (Principle 2); Annex 1, section 2.8 sets out the process. |
| Keeps source records | Source records should be attributable, legible, contemporaneous, original, accurate and complete (Annex 1, 2.12.2). |
| Records and reports adverse events | Adverse events go to the sponsor as the protocol specifies; serious adverse events go immediately (Annex 1, 2.7.2). |
Where the rule comes from
ICH E6(R3) does not name the CRC role. It gives duties to the investigator, who may delegate trial activities to qualified, trained staff while keeping overall responsibility (Annex 1, 2.3). Most of a coordinator's work is delegated investigator duties.
Why it matters
The CRC role is the widest door into the field. It rewards organization, careful documentation, and patient communication more than it requires a specialized degree.
Example
On a busy clinic day the CRC consents a new participant, runs a scheduled visit, records two adverse events in the source notes, and hands over drug supplies to the pharmacy, documenting each step as it happens.
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