The Coordinator Everyone Depends On
You are PM for a 6-site study. At Site 3, a single research coordinator, "Dana," has run the study essentially alone for 14 months: she does all screening, consenting, data entry, and query resolution, and she is the only person at the site who knows the ePRO system. She is highly capable and has never missed a deliverable. In the last 6 weeks: query resolution at Site 3 has slipped from 5 days to 19 days; two scheduled monitoring visits were rescheduled by the site; and Dana mentioned in passing on a call that she is "covering three studies now" because the site hasn't backfilled a departed colleague. Your PI is at another site and has never met Dana. The site's principal investigator signs off on visits but delegates everything operational. Enrollment at Site 3 is the highest in the study.
1. Diagnose what is happening at Site 3 and identify the risks you now own.
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Diagnosis: this is a single-point-of-failure that is already degrading, and the degradation is being masked by good enrollment.
The symptoms are consistent and point one direction:
- Query resolution 5 → 19 days is the clearest signal. It's a task with a measurable baseline, and it has roughly quadrupled. That is not a blip; it's a capacity problem showing up in the first place it can.
- Two rescheduled monitoring visits - rescheduling is what a site does when it can't face an audit of its own backlog. It often precedes a finding.
- "Covering three studies now" - the root cause, stated plainly. Dana is absorbing a colleague's workload with no backfill.
- High enrollment is the trap. It makes the site look healthy on the dashboard while the operational backlog grows underneath. If you only looked at enrollment, you'd never see this.
Risks you now own:
- Key-person risk. Dana is the only person who knows the ePRO system at the site. If she leaves or is out for two weeks, Site 3's data flow stops. This is the highest-severity item and it's currently unmitigated.
- Data quality risk. 19-day query resolution means queries are aging; aging queries correlate with transcription errors, missed visits, and unreported AEs. The backlog may already contain unreported safety information.
- Compliance risk. Rescheduled monitoring visits plus a backlog is the pattern that produces significant findings at an audit. The PI's delegation of "everything operational" without oversight is itself a GCP concern - the PI is responsible for the conduct of the study and cannot delegate that responsibility away.
- Safety risk. If Dana is overloaded, the first thing that slips after queries is AE reporting. You don't know that it has, but you can't assume it hasn't.
What you do not do: treat this as a performance problem with Dana. She is the most capable person at the site and is being set up to fail by a staffing decision she didn't make. Framing it as her failure loses you your best coordinator.
2. What is your intervention plan, and how do you handle the fact that the site's PI is disengaged?
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Immediate (this week):
- Call Dana directly and ask, plainly, what she needs. Confirm the three-study load and get her estimate of hours per week on your study versus the others. Do not lead with the query metric - lead with the capacity question, because that's the cause.
- Ask for a targeted check on safety reporting - specifically whether any AEs or SAEs in the last 6 weeks were reported late. Frame it as a routine data review, not an accusation, but get the answer. This is the one item you can't wait on.
- Un-reschedule the monitoring visit and ask the monitor to prioritize query aging and AE reporting at Site 3. A monitoring visit is exactly the tool for this situation; letting it stay postponed removes your visibility.
Short term (2-4 weeks):
- Go to the site's research leadership, not just the PI. The PI is disengaged and delegating operational responsibility without oversight - asking them again is unlikely to change anything. Escalate to the research office or department head with a factual, non-punitive framing: "Site 3 is our highest-enrolling site and its coordinator is covering three studies without backfill; we're seeing query aging and we're concerned about continuity and data quality. We'd like to discuss backfill or a second coordinator." Bring the enrollment numbers - you're protecting a high-value site, not complaining about it.
- Reduce load where you can. Can the sponsor absorb some query resolution centrally? Can the ePRO vendor provide direct support to reduce Dana's system burden? Small transfers of work buy time.
- Address the key-person risk directly. Ask Dana to document her ePRO procedures and cross-train one other person at the site, even part-time. This is the single most valuable thing she can do for the study and it protects her too.
On the disengaged PI: the PI's signature on visit reports while delegating all operations is a real GCP gap, and it's the site's to fix, but you can influence it. Put the concern in writing to the PI and the research office: the PI is accountable for study conduct and needs to be aware of the coordinator's capacity and the query backlog. Don't frame it as a threat; frame it as "you are accountable for this and here is what you need to know." If the site won't act and data quality continues to degrade, escalate to your sponsor's clinical operations lead and consider whether Site 3 should be flagged for a for-cause monitoring visit. That is a serious step at your highest-enrolling site - which is exactly why the earlier, softer interventions need to happen now.