Run the day-to-day work of a clinical-trial site the way a Clinical Research Coordinator does, and check it the way a Clinical Research Associate does: get a site initiated, keep the investigator site file in order, find and pre-screen participants, conduct and document the consent visit, confirm eligibility and enrol, keep source records that will stand up to review, prepare for a monitoring visit with source data verification, and close the site out. It teaches site practice under ICH-GCP; it does not repeat GCP principles, and it is not CTMS, EDC or eTMF software training.
Needed across
What you will be able to answer
You join a hospital site as a coordinator two weeks before the CRA's first monitoring visit. The site file is half-filed, two participants signed an older consent version, one screening log entry has no eligibility notes, and lab reports are only in the hospital system. What can you produce before the CRA arrives?
A visit-readiness pack: an ISF gap list against the expected contents with current versions confirmed; a re-consent plan for the two participants on the approved new version, documented in their source notes; a completed screening log with eligibility evidence traceable to source for each entry; certified copies or access arrangements for the lab source; and a list of the data points the CRA is likely to verify first — without backdating any record or changing a signature.
One payment
₹99
The videos are free
Course outline
Concept 1
Concept 1 · Follow a trial through one site from start-up to close-out
Concept 2
After: site-trial-lifecycle
A site isn't open because the contract is signed — it's open when the initiation visit says it's ready.
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Concept 3
After: site-initiation-visit
The site file is where an auditor starts — and where a superseded consent form is easiest to spot.
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Concept 4
After: investigator-site-file
Most sites miss their enrolment targets — usually because pre-screening was guesswork.
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Concept 5
After: recruitment-and-prescreening
A signature on the right page isn't enough — the source note has to show how consent actually happened.
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Concept 6
After: conducting-the-consent-visit
Every enrolled participant needs evidence for every criterion — one unsupported tick is a protocol deviation.
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Concept 7
After: screening-and-enrolment
If it isn't written down at the time, by someone you can identify, it didn't happen.
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Concept 8
After: source-documents-alcoa
SDV is the CRA holding your CRF up against your source — line by line.
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Concept 9
After: monitoring-visit-and-sdv
A site's last visit decides whether its records can still answer an inspector's questions years later.
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23 candidates did not meet the course criteria.
The sponsor's field liaison to hospital trial sites. You travel to sites to conduct Source Data Verification, audit protocol adherence, and monitor patient safety. Direct fresher entry is rare due to regulatory risk — the standard route is 1–2 years as a CTA or CRC first, then Junior CRA. Well-paid and high-autonomy, but monitoring travel of 50–80% is the defining lifestyle trade.
9 mapped employers
Explore path →Site-based trial coordination at hospitals and Site Management Organizations — the most direct use of your Pharm.D hospital exposure in clinical research. You screen and schedule trial participants, support informed consent, maintain the Investigator Site File, coordinate lab samples, and enter data into eCRFs. Your internship-year hospital network is often the hiring pipeline. A common springboard to CRA roles on the sponsor side.
9 mapped employers
Explore path →