In a separate post I provide you tips and advice for motivating and working well with your coordinators. However, sometimes it is hard to get a Study Coordinator to answer the phone, email, or query requests. Other times they are behind on their Screening/Enrollment logs, supply requests, data entry, etc. As a CRA Site Manager, this can adversely affect your metrics, status reports, or sense of general management for the site. If the coordinator is a repeat offender or a general flake you will have to escalate the issue to the Principal Investigator and if necessary to the sponsor; enrollment or study payments may be held until the situation is rectified or the site may be closed.
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.
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| You catch more flies with honey... Bee prepared. Never assume you have the whole picture. Show compassion and find out what is going on with your coordinator. This will make great in-roads towards a healthy and productive professional working relationship. |
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
5 comments:
It 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.
Thanks 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.
Hi 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.
Hello Nadia,
have you ever dealt with a site with documentation issues, if so what advice would you give in handling that situation.
1)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?
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