In many organizations, a standard working day is approximately eight hours. However, Clinical Research Associates, Project Managers, and other clinical operations staff may regularly work ten or more hours per day, especially during critical study phases.
If only eight hours are recorded in time sheets while ten hours are actually worked, two hours per day become unaccounted operational effort.
Individually, this may appear minor. Over the duration of a clinical trial, the financial impact can be substantial.
Financial Example: Unaccounted Hours Over a Project Duration
Consider a simple example.
Assumptions:
- Each employee works 2 additional hours per day that are not recorded
- 10 employees are assigned to the project
- Project duration is 5 years
- Average working days per year: 220
- Average fully loaded cost per employee hour: USD 100 (example value)
Step 1 – Additional Hours per Year
2 hours/day × 220 days = 440 hours per year per employee
Step 2 – Additional Hours for 10 Employees
440 hours × 10 employees = 4,400 hours per year
Step 3 – Over 5 Years
4,400 hours × 5 years = 22,000 hours
Step 4 – Financial Value
22,000 hours × CHF 100/hour = USD 2,200,000
Interpretation
In this simplified example, unaccounted overtime over a five-year project with ten employees could represent more than two million USD of operational effort that never appears in study budgets or financial reports.
Even if the hourly cost assumption is lower, the financial magnitude remains significant. The key point is not the exact number, but the realization that small daily overtime can accumulate into very large operational effort over long projects.
If this effort is not recorded:
- project budgets underestimate true effort
- future projects are budgeted too low
- management does not see the real workload
- inefficient processes remain hidden
- staffing needs are underestimated
Why Recording All Working Time Matters
Recording all working time is not primarily a billing exercise. It is a management and process improvement tool.
When all working time is recorded and allocated to projects or operational categories, several things become visible:
- projects that require more effort than planned
- scope creep and additional work
- inefficient processes and administrative burden
- training needs for employees
- unrealistic timelines and budgets
- system or process inefficiencies
Without accurate time recording, management decisions are based on incomplete information. Projects may appear profitable or on schedule only because part of the work is not recorded.
From Time Recording to Process Improvement
The objective should not be to control employees or track every small task. The objective should be to understand how much effort is actually required to run clinical trials.
If actual effort is known, organizations can:
- improve budgeting assumptions
- simplify processes
- improve system integration
- adjust staffing levels
- identify training needs
- reduce administrative burden
In this sense, recording all working time is not only about accounting. It is about making work visible so that processes and budgets can be improved.
If project teams consistently work ten hours per day while only eight hours are recorded, the organization may believe that staffing levels, systems, and processes are adequate. In reality, the project is only functioning because employees work beyond standard working hours. In such situations, accurate time recording is not only a financial matter but also a workforce protection mechanism. If overtime becomes visible, HR can monitor workload, management can improve systems or provide training, and organizations can make informed decisions about staffing and budgeting.
Conclusion
Unaccounted costs in clinical research often arise from overtime work that is not recorded in time sheets or project accounting systems. While this may help projects remain within budget in the short term, it hides the true operational effort required to run clinical trials.
A simple way to make unaccounted costs accountable is to ensure that all working time is recorded and allocated to projects or operational categories. When every working hour is visible, scope creep becomes measurable, absorbed costs become visible, and inefficient processes become easier to identify.
Clinical trial costs are not only determined by what is written in the study budget, but by how many hours are actually required to run the study.
References
- The Silent Epidemic: Addressing Burnout in Clinical Research Staff https://www.linkedin.com/pulse/silent-epidemic-addressing-burnout-clinical-research-staff-agrim-jain-7cpoc/
- Why does the CRA role so often lead to overload and burnout https://www.reddit.com/r/clinicalresearch/comments/1qgy713/why_does_the_cra_role_so_often_lead_to_overload/
Note: The examples in this article are conceptual and illustrative and are provided for educational discussion. They are intended to explore the relationship between planned effort, recorded effort, and actual effort in complex project environments, and do not describe any specific project or practice.
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