so what exactly is an oversight CRA we're gonna talk about that coming up
hey guys ECR G here back with another video today
we're gonna be talking about what exactly is an oversight CRA now this is
slightly different than a normal CRA a clinical research associate who
typically goes on site to the sites monitors their datas interacts with the
study coordinator with the pis etc source data verifies does IP
accountability and all the things that c arrays do collect essential documents
and all the things that they do so this is slightly different than that in the
sense that they are put in place by the sponsor to oversee the CRA s
so the sponsor is going to put in place what they call an oversight CRA and this
can be someone who works directly for the sponsor like in their organization
and they are gonna oversee the CR OS CRA s so typically one oversight CRA can
oversee up to ten of the CRO series so why am i doing a video on this why is
this coming up more and more you know what is the purpose of this oversight
CRA aren't the CRA it's just amazingly good at their job and you know they're
gonna be excellent anyway so why do the sponsor me to oversee them aren't they
being overseen anyway well not that is not exactly the case the sponsors are
having a trouble by the sponsors are having trouble with looking and seeing
how well the CRA are doing and they have found that CRA s are not matching up to
the quality agreement set forth when it comes to successfully monitoring studies
a large number of the findings that are being found by the FDA now a large
number of finds that the FDA is found is that you know there's a failure to
ensure proper monitoring of the study so what does that mean that means that the
data is going to be bad there's be a lot of notes of files
I mean basically the main thing is the data's gonna be bad
so they're finding the CRO is finding I mean the sponsor is find that there's
gonna be a lot of bad data and that is extremely costly to them so a lot of
people are probably thinking if you're listening to this
well isn't an oversight CRA gonna be pretty costly as well especially if
you've got this is a new person that you have to add on to the study to every
single study you're running you know a new position well what they're finding
is there's something called the Hawthorne effect now when you add
someone in basically the Hawthorne effect says and to put it simply people
tend to perform better when they know they're being watched people tend to
perform better when they know they're being watched so that's the same thing
for C arrays if they know someone is closely watching what they're doing and
monitoring them they're gonna typically perform better closely follow the data
collect better essential documents more submissions to the TMF whatever it
whatever it is they want to measure but they have found that due to the
Hawthorne effect that they are going to perform better when they put an
oversized CRA in place so this is going to cost less money in the long run when
the FDA has findings and rejects their clinical drug from coming to the market
or progressing into a different phase of the trial they're gonna be glad that
they spent money on an oversight CRA so that's basically what they're saying so
basically yeah the the typical role of the oversight CRA is just to monitor the
CRO CRA and they said I'm reading off an article here I recently found about this
topic because this is pretty new in the CRO landscape in the pharmaceutical
landscape they typically didn't have someone so like dedicated to overseeing
the monitors they had only the sponsor team always has a
management team and they kind of oversee everything that the CRO does but nobody
specifically and you know occasionally that project manager would go out on
site with the monitor where they'd have a clinical person that would go on side
with a monitor from time to time but no one that was dedicated to it so you know
basically this oversight CRA is gonna be someone who's got a lot of experience in
monitoring and they want them to be a regulatory expert next to a regulatory
and quality assurance and the big thing that they're gonna want is to have the
experience and the ability to create capital plans so if you don't know what
clappa plans are that's basically a corrective action plan and these are all
over clinical research you can give them the studies if this if if a site is not
performing up to par you put them on a corrective action plan if a team is not
performing up to par you put them on a corrective action plan etc etc so this
is this is unique idea if you're interested in being a CRA this could be
a good career path for you if you want to work at the sponsor level after
you've done you know some years in the CRA role because this is a new role come
up and coming and you know I think this is great because sponsors are gonna be
more comfortable putting their trials and Ciro's hands if they know that the
monitoring is gonna be data is going to be closely watched by them and you know
I think it's overall a win win because they're gonna be a lot happier with the
product they get back at the end of the study when they realize that their data
is gonna be a lot cleaner so I and you know I recently saw this position up
there I didn't realize because sponsors also have CRA is like regular CRA
position to to and I had applied for it but I did not realize it was an
oversight to see array so this me talking about this is actually pretty
coincidental also this is one the reason I want to talk to you about it because
I'm sure a lot of people did not know that there was such thing as an
oversight to see array this is because it's becoming pretty new and pretty
popular pretty so look for that I think we're also
gonna see sponsors hiring more series also so if you are looking to be a CRA I
would definitely look out for sponsor positions where they are willing to
train you and bring some of the monitoring in-house if they bring that
monitoring in-house then they don't need an oversight Cierre anymore so I think
that's the end goal for them also but as always guys if you're interested in
getting your resume reviewed if you are having a hard time getting in the
clinical industry clinical research industry or you just want to set
yourself apart from everybody else and have that stellar resume that you need
you can email us at elite clinical group at gmail.com to get your resume in the
right persons hands and you know finally I mean a lot of people they apply for
jobs but the resume is one of the most important things that you need to have
because that's going to catch people's eye that's gonna catch that recruiter
that hiring managers I to say hey we should interview this person and get
them to the next level and we've helped a lot of people you know it's just a
great process to go through in general because it allows you to see your
strengths and weaknesses of your resume and for you to think about think about
that in a good manner and also help prepare you for your interview when you
need to know your resume backwards and forwards when we go through and break it
down like this so once again email us at elite clinical group at gmail.com
if you want to do some interview prep also we are offering that email us there
also of course you want to have that confidence when you go into your
interview and the confidence really starts early in the process with your
resume but it continues all the way on through the interview preparation so
email us there also like this video subscribe hit the podcast link and write
us a review all right guys take care