Clinical Research Coordinator
Runs the trial at the site. Turns a protocol into visits that actually happen, with consent and data that will still stand up when someone reads them years later.
8 FACETS · THREE ALTITUDES · FREE, NO ACCOUNT REQUIRED
What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
Kept on this device, and on your account when you are signed in. It orders your route; it never hides a page, and it is not a judgment about you.
You organise everything that happens to a patient in a clinical trial at your hospital or clinic, and you write down what happened.
You screen and consent participants, schedule and run visits to protocol, collect and enter data, manage investigational product accountability at the site, and prepare for monitoring visits and inspection.
Almost every data-integrity finding in clinical research traces back to the moment something was recorded at a site. You are that moment, repeated a few thousand times.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
At the investigator site, between the protocol and the participant in front of you.
- Protocol approval, ethics approval and site activation
- Monitoring and data review by the sponsor
- Every analysis built on the data you record
- A protocol that can actually be executed at your site
- The investigator’s oversight and availability
- Investigational product supply and its accountability records
- The investigator
- The sponsor and its monitors
- Every downstream analysis
- Contemporaneous, accurate source records
- Consent process execution and its documentation
- Protocol adherence in day-to-day conduct, and reporting deviations honestly
- The protocol or amendments to it
- Medical decisions about a participant
- The sponsor’s data analysis
- The principal investigator, for anything clinical or any protocol deviation
- Immediately, for a safety event or a suspected consent failure
- Source documents and case report form entries
- Consent documentation
- Investigational product accountability records
- Deviation records
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Clinical Research Coordinator yet. 14 are published across the registry, and this role is not among the ones they name.
Read the standard and its stated coverage →STARTER KIT · 4
Templates and working tools for what this role produces or decides first. A starting shelf, not a complete one.
A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Clinical Operations pathway, then Practise in a scenario, then what any of it evidences. Skip any of them — the order does not change.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- ICH E6(R3)Good Clinical Practice (GCP)ICH · last revised 2025-01-06
- ICH E8(R1)General Considerations for Clinical StudiesICH · last revised 2021-10-06
- 21 CFR Part 312Investigational New Drug Application (IND)FDA · last revised 2023-01-01
- 21 CFR Part 50Protection of Human Subjects (Informed Consent)FDA · last revised 2024-01-01