CLINICAL OPERATIONS · OCT 2, 2026 · 7 MIN READ
More trials with the same research team: clinical research coordinator workload
Adverse event documentation recurs at every on-treatment visit, so it takes a recurring share of clinical research coordinator workload and limits how many trials a cancer center can carry.
Burna AI Team
Clinical research coordinator workload sets how many trials a cancer center can carry. Every study consumes a share of coordinator hours, and a research office opens new studies only as fast as those hours allow. Adverse event documentation is one of the most repetitive parts of that workload, because it recurs at every on-treatment visit of every patient on every study. Lower what that work costs per visit, and the same research team can carry more trials.
What sets clinical research coordinator workload?
Trial acuity sets clinical research coordinator workload. Which patients are on active treatment, and on what kind of trial, counts for more than the number of patients a coordinator carries. Fifty-one community-based research programs in 30 states entered six months of workload data into ASCO's Clinical Trial Workload Assessment Tool. Staff whose patients were receiving treatment scored highest, and the authors concluded that trial-specific acuity measures workload better than a patient count (Good et al., Journal of Oncology Practice, 2016).
The Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) in Meldola, Italy, built a comparable tool, the IWAT, which divides each coordinator's load into protocol work, on-treatment patients and follow-up patients (Fabbri et al., JCO Oncology Practice, 2021).
| Source | What it measures | What it shows about workload |
|---|---|---|
| ASCO Clinical Trial Workload Assessment Tool (2016) | Monthly staff acuity per trial, and patient encounters | Patients on treatment carry the most work; treatment and industry trials score highest |
| IRST Workload Assessment Tool, IWAT (2021) | Protocol work, on-treatment patients, follow-up patients | Study scores ranged from 2 to 188, median about 21; a monthly score of 500 to 600 was judged appropriate for a full-time coordinator |
| AACI CTO Staff Retention Task Force (2022) | Recommendations from a survey of cancer center directors | Measure effort with acuity tools, move data entry to support staff or vendors, use technology to cut administrative burden |
The Association of American Cancer Institutes (AACI) task force also shows where the ceiling sits: when staff capacity is limited, research leadership should support investigators in resisting sponsor and CRO requests to open low-priority trials (AACI Commentary, September 2022).
Why adverse event documentation grows with every patient on treatment
Federal rules make the work recur. An investigator must keep case histories that "record all observations and other data pertinent to the investigation" for each subject (21 CFR 312.62(b)). The investigator must record nonserious adverse events and report them to the sponsor on the protocol's timetable. An investigator must report any serious adverse event to the sponsor immediately, whether or not it is considered drug related, with an assessment of whether there is a reasonable possibility the drug caused it. Study endpoints that are serious adverse events are reported as the protocol specifies, unless there is evidence of a causal relationship (21 CFR 312.64(b)).
At the site, each event becomes a chain of steps, most of them performed by a coordinator and most of them a second pass over the same clinical text:
- Find the event in the note, lab values and medication changes included.
- Choose the CTCAE term in the version the protocol names.
- Grade it against that term's criterion.
- Draft the attribution to each drug in the regimen for the investigator to assess.
- Assess seriousness, which is separate from grade.
- Enter the event in the case report form.
- Answer the monitor's queries during source data verification, sometimes months later.
- Reconcile serious events with the sponsor's safety database before lock.
Take diarrhea on a two-drug regimen. The note records five more stools a day than usual, so the coordinator chooses Diarrhea and grades it 2: CTCAE v5.0 and v6.0 both set grade 2 at an increase of 4 to 6 stools per day over baseline. Attribution is drafted once per drug, seriousness is assessed separately, and each judgment can come back as a query.
Attribution carries its own load. A 2019 report from a toxicity-attribution workshop held in Silver Spring, Maryland, listed the costs and time of collecting attribution data among the challenges to solve; regulators, sponsors, CROs, investigators and research staff took part (George et al., Cancer Treatment Reviews, 2019).
The CTCAE version transition adds more. NCI released CTCAE v6.0 in July 2025 (NCI CTEP). CTCAE v6.0 has 850 terms: 45 new, 7 renamed, and 376 reworded at one grade or more since v5.0. CTCAE v5.0 has 837 terms. Each protocol names its version, so a research office with studies opened on both sides of the transition grades against CTCAE v5.0 and v6.0 at once. The differences are mapped at every CTCAE v6.0 change, term by term.
Is there a research coordinator shortage?
Yes. Cancer center directors and site networks both report a research coordinator shortage, and clinical research coordinator turnover is the sharper problem. In a 2022 open letter to sponsors and CROs on workforce retention, the Society for Clinical Research Sites (SCRS) reported that site networks were averaging turnover of 35 to 61% among patient-facing staff, against 10 to 37% before the pandemic. Merck cited the same range in its January 2023 response to the SCRS open letter.
In AACI's March 2022 survey of cancer center directors, departing clinical trials office staff cited higher pay at CROs and in biotech, limited career growth, and burnout from "heavy workloads and not enough staff to manage trial portfolios" (AACI Commentary, September 2022).
Turnover makes adverse event documentation a training problem too. A new coordinator learns grading from whoever has time to teach it, the standard drifts with each handover, and queries on a departed coordinator's events land on someone who never saw the reasoning.
What does adverse event work cost a research office?
In an illustrative portfolio of 120 on-treatment visits a month, grading alone takes 60 coordinator hours, more than a third of one full-time coordinator, before attribution, case report form entry and queries. The inputs are examples:
| Input | Example value |
|---|---|
| On-treatment visits across the portfolio, per month | 120 |
| Adverse events documented per visit, on average | 2 |
| Minutes to grade one event by hand (replace with your own timing) | 15 |
| Coordinator hours per month spent on grading alone | 60 |
A full-time year is 2,080 hours, about 173 a month, so 60 hours is 35% of one coordinator. The AE labor cost model uses the same 2,080-hour base and prices the same work for your own portfolio from trial count, coordinator and investigator headcount, the share of their time spent on grading, query volume and loaded salary cost.
To turn hours into studies, divide the coordinator hours released each month by the hours one study of comparable acuity consumes, which the ASCO or IRST tool above helps estimate. The result is the number of comparable studies the same team can add.
Burna AI charges one published rate: $10 for each clinical trial visit processed, however many events that visit produces. An annual subscription includes a block of visits at that rate, so every subscription dollar comes back as work done.
Hours that stop going to a second pass go to work that needs a coordinator: the patient in the room, consent, eligibility, and the start-up of the next study, as set out on how Burna AI works with cancer center research offices. The one-page case for whoever signs presents cost and capacity in that order.
How Burna AI turns adverse event documentation into a review step
Burna AI reads the note from the medical record, or from a visit recorded in the room, and drafts what steps 1 to 4 assemble by hand, plus the reports that follow:
- Every adverse event graded against the CTCAE version the protocol names, with v5.0 and v6.0 live on one engine.
- Attribution scored against every drug in the regimen, using the WHO-UMC and Kramer algorithms, with the reasoning shown.
- A MedDRA LLT code with each grade, on the MedDRA release of the CTCAE version that graded it.
- Every grade traced to the line in the medical record that produced it; a grade whose citation set is incomplete is flagged before it is signed.
- FDA MedWatch, IRB and serious adverse event reports produced from the graded record.
The coordinator reviews a page instead of building one, and the investigator signs. A grade becomes a record only when a qualified investigator signs it under 21 CFR Part 11. Behind the page, twelve specialized agents run in a cascading constraint pipeline.
Two capabilities on the public capability record answer turnover directly. Calibration training for coordinators lets a new coordinator grade a synthetic case and compare against the engine criterion by criterion, while an educator tracks competency. Blind grading lets several raters grade the same case unseen by each other, routes disagreements to an adjudicator and measures inter-rater agreement, so a research office sees where its standard drifts.
How inconsistent grading turns into queries and rework
An event graded or attributed differently at two visits, or by two coordinators, can draw a monitor query, and each query costs coordinator and investigator time. The variability belongs to the task rather than to the people doing it. Two reviewers who independently read 100 notes from on-treatment radiation therapy visits for CTCAE v5.0 toxicities agreed at an unweighted Cohen's kappa of 0.68 and a weighted kappa of 0.59; the authors concluded that toxicity identification is a complex and error-prone task (Fairchild et al., International Journal of Radiation Oncology, Biology, Physics, 2020).
Attribution moves too. In the placebo arms of two phase III trials, when the same adverse event was reported for the same patient at several visits, its attribution category changed at least once in 36% and 31% of cases (Hillman et al., Journal of Clinical Oncology, 2010).
An entry that arrives with its criterion and source sentence attached gives the monitor less to ask about. Burna AI's job is to help elucidate the safety profile: the criterion, the source line and a per-drug attribution in front of the investigator, so their judgment is equipped rather than replaced.
Common questions
How many trials can one clinical research coordinator manage?
There is no fixed number, because studies differ widely in acuity. IRST's tool scored individual studies from 2 to 188, with a median near 21, and judged a monthly score of 500 to 600 appropriate for one full-time coordinator. Scoring your own portfolio shows which studies consume the hours.
How can a cancer center increase clinical trial capacity without hiring?
A cancer center increases clinical trial capacity without hiring by lowering the coordinator hours each study consumes, and by choosing studies for the hours they take. Five steps:
- Score every open and proposed study by acuity rather than patient count.
- Remove transcription and repeat reads of the same note.
- Give new coordinators a structured calibration path.
- Decline low-priority studies when capacity is short, as AACI recommends.
- Price today's adverse event workflow with the AE labor cost model, so the case reaches whoever signs with a number attached.
Does AI grading replace the coordinator or the investigator?
No. Burna AI drafts the grade, the attribution and the code with the evidence attached, the coordinator reviews it, and a qualified investigator signs it before it becomes a record.
Burna AI is the AI platform for accelerated clinical research, from first-in-human trials through postmarket surveillance. Burna AI performs automated adverse event grading and attribution in real time, providing clear rationale and audit-ready evidence, including generation of IRB, sponsor and FDA reports. Burna AI delivers CTCAE v5 and v6 grades and MedDRA LLT codes on every encounter; enabling standardization, cross-site consistency and accuracy of clinical research data. AI suggests, clinicians decide. Human-in-the-loop, always.
Planning next year's trial portfolio against the research staff you expect to have? Book a 15-minute conversation.