Lead CRA Q&A: Dealing with Poor Performance Feedback

Anonymous said..I understand the productivity loss, time, costs, etc of choosing an inadequate site; however, what are the ramifications against a CRA who chooses a site that turns into a “dud” site?APRIL 7, 2010 2:00 PM

The Lead CRA responds…

Wow, this is a challenging question.  I only choose great sites that end up as top enrollers and execute the protocol flawlessly so I am completely unqualified to answer – ha!  In all seriousness, I think that in any job or task where you can demonstrate that you performed methodically, deliberately, and intelligently the study team would be hard pressed to fault you in your efforts.  If you build a strong reputation for yourself through quality work and your team trusts you, the backlash from these types of issues will likely be minimized but you still may find yourself “on the hook” for a poor performing site.  During my site selection efforts I keep a log of my activities and communications so I can reflect back on the process 1) to look for potential efficiencies for next time 2) to serve as a training tool for Junior CRAs that I mentor and 3) to demonstrate/remind myself/others that I was diligent and thorough in my original efforts (my colleagues and I lovingly refer to this type of documentation trail as CYA).

If I am called to task on poor performance, I will have some documentation to defend my actions, explain my thinking at the time (hindsight is 20/20), and deflect some of the backlash.  This is a delicate line because you want to explain the history behind errors but you need to be careful not to dwell and beat yourself up too much.  You have to move forward and get recruitment back on track – be proactive and start brainstorming solutions.  Just like we tell our study sites, you acknowledge the issue, you create a plan to avoid the issue in the future (obtain guidance and re-training as appropriate), and you implement that revised process.  So you picked a “dud” site, coach them, encourage them, and try to salvage things if at all possible.  How cool would it be if you worked hard enough and your problem site transformed into a model site?  If all else fails, the study team may elect to close the site and focus efforts into better performers but I hope you have been tracking your site correspondence and have been a good site manager and partner (and can prove it with documentation).

Only an unreasonable employer expects you to perform perfectly at all times.  The best we can train for is to develop a toolkit of monitoring skills and a clin ops intuition for making the best decisions.  At the end of the day, we are human and fallible and need to be able to accept our failures when they do happen (and they will happen, this can be a challenging job).  That said, someone does sometimes need to take a fall and as a CRA you may be grilled or disciplined by the study team.  You may receive poor performance feedback at a review or have an uncomfortable conversation with your supervisor or study team.  In my career,  I have known CRAs who were yanked off of trials or “sacrificed” for political reasons not necessarily performance reasons.  I’ve witnessed CRAs be unfairly scrutinized or singled out in meeting/telecons for site performance issues that were more or less out of their control.

Having your work or ideas criticized can be humbling and may not be warranted, but it is bound to happen at some point.  I hope for every CRA that negative feedback is always delivered respectfully and constructively.  When your work does not meet your employer’s expectations, limit the excuses, graciously accept that feedback, and improve. A mistake can be devastating or it can be a development opportunity.  In other words, you can’t undo errors, but you absolutely have complete control over how you react and recover from a mistake.  I keep track of my successes at work in an email folder called ‘Praise’.  For example, if I get a note from a peer or a higher up complimenting my work, I file it away for later.  Reviewing the items in the ‘Praise’ folder is a great pick-me-up when I’ve had a challenging day or even to share with my supervisor when we are reflecting back on my overall performance at review time.  I’ve veered a bit off topic but I hope my thoughts on dealing with poor performance feedback are helpful and have addressed your question.

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About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.