How can we motivate?
Will we be out of touch forever?
However, nine times out of ten, I have found that lack of communication or poor performance from the site to be isolated and due to some temporary interruption/issue thereby calling for extra understanding on my part. You never know what they have going on outside of work. For example, one time my SC was dealing with the recent suicide of his ex-wife and having to care for a new baby so all the work was slipping. They may have recently lost a sibling, parent, friend, child, etc. and that can affect their work. I had another coordinator who took a month off work to study for her medical licenses. One coordinator frequently fell asleep at her desk due to uncontrolled narcolepsy. The list of distractions/personal issues goes on and on and sometimes their workload is truly too high.
Intervene Early
I have always felt more compassion and understanding once I learned what was going on. It is important not to let the situation spiral too far by keeping a pulse on your site’s activities and to strike up a dialogue the moment the work starts to slip or unusual patterns/delinquencies start to emerge. If your coordinator isn’t producing or available, pin them down and ask what the issue is and whether there is anything you can do to help. They don’t have to give you all the details in order for you to help them come up with solutions to get the work done. Coordinators are pulled in many directions but you always need to pay attention and work with them to achieve the study goals. So the take away is to be as patient as possible with your coordinator. When you are frustrated with a coordinator who is falling short, always stop to ask, “What is up with this coordinator?” so you can be pro-active, problem solve, and best maintain the relationship with the site.
You may also like…from The Lead CRA archives:
- Motivating Your Study Coordinators February 2011
- Investigative Site Recruitment Plan September 2010
- Routine Monitoring Visits March 2008
6 Comments
CRA.IN
August 21, 2014Hi,
This website is quiet amazing. Thanks to the lead-CRA for such realistic post. This is how good CRA deals with difficult study co-ordinators. I agree with the every bit of what is mentioned in this article. I am doing monitoring in India and over the period of 1 year I developed a good friendship with all my study co-ordinators. To the extent where they used to take me out for shopping local stuff and sightseeing nearby places. Maintaining good personal rapport is the key.
@ lancelot that sounds really difficult situation to deal with. I hope these trials are non-interventional or observational trial.
@palapagoss It would not be appropriate to generalise the situation based few experience. Difficult investigators and co-ordinators exist everywhere. Such kind of situation arise because of approach of people who are conducting trials, the sponsors attitude and also the clinical operations manager who are directing the staff.
Alex
September 12, 20121)what are the MOST challenges in CRA?
2)What is the most dissapointing thing in CRA?
3)What is the least thing you can do in cra?
4)What is the most Exiting thing in cra?
5)What is the difficult problem you faced in cra and how you resolved it ,please give me a example?
6)What you will do if Cordinator is not in the site when you visited the site?
7)What will you do if some documents missing in the regulatory file?
what are the essential documents in regulatory
file and what are 5 most important?
8)What is the exciting thing in cra?
Please kindly reply some of this were asked in the interview?
Anonymous
May 25, 2012Hello Nadia,
have you ever dealt with a site with documentation issues, if so what advice would you give in handling that situation.
The Lead CRA
January 15, 2011Hi Lancelot, I am hoping to expand my China experience as I think it is a really exciting frontier for clinical trials. I am interested to hear that the PI is often the coordinator; indeed that would present some interesting challenges. Here in the states I would be unlikely to select or qualify a site without a dedicated coordinator. It is helpful to know that I might face this issue in China trials. Thanks for following the blog and for your comment.
palapagoss
January 15, 2011Thanks for your post. This issue really hits me. I think this would apply to most clinical research site in Asia that CRAs must support and deal with study coordinators in both personal and study issues. A CRM in the previous company told me that she just did not understand why I did always have the issue for achieving my request from the sits.
lancelot
December 28, 2010It is lucky that you have a study coordinator. I am from China, and most of the site will not have a study coordinator. The physician will both be the investigator and study coordinator, which will cause a situation difficult to deal with. The physician is fulltime medical practice and only conduct the study in her/his spare time. So CRA in China is hard to communicate with investigator frequently.
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