so what is the difference between an in-house CRA and a field CRA coming
right up after the intro hey guys ECR G here back with another episode
today we're gonna be talking about what is the difference between an in-house
CRA and a field CRA so I've done videos on you know what what in how CRA does
and I've done videos on what a CRA does but we've had a subscriber request to do
a video kind of comparing and contrasting the two so we're gonna get
into that today about you know what an in-house does and what a CRA does in the
field but before we get into that I just want to let you guys know about the
resume review program and some of the coaching we've got going on the resume
review program is for anybody who's having a hard time getting into clinical
research or having a hard time changing positions within the clinical research
field now this can be a very very hard thing to do once you get into a clinical
research position and you may not know how to best position yourself to change
positions within the field and then we've got interview coaching / interview
prep going on - so a lot of people get nervous before their first interview
they don't know what kind of questions are gonna be asked they don't really
know how the interview is gonna go so we're gonna go over all of that if you
are interested in any kind of interview coaching so email us for both of those
at Ali clinical group at gmail.com but back to the original purpose of this
video and I think it's best to start out with what a CRA needs to do on-site why
does the CRA go on-site and a CRA goes on-site to do a number of things they're
going to detect fraud that's a big one they're going on-site to make sure that
you know there are people there that are actually conducting research they're
going on-site to talk to the PI they're going on-site to talk to study
coordinators make sure they're actually doing what they're supposed to be doing
and then there's some of the other reasons why I see a mango on-site is a
to do IP accountability now that's just that's just a fancy way of saying cow
the medicine and they are counting the medicine that is left that the patient
has taken they don't want the patient be taking less medicine than is required
they don't want them under dose and they don't want them taking more medicine as
required especially in situations where a patient may see that medicine is
working you know people may have a tendency to kind of take more medicine
than they need and save it for after the clinical stuff after the clinical study
so monitor is gonna go on there and count it making sure that's not
happening and that's one of the things that has to be done on-site you cannot
do that remotely right now there's no there's no good solution for that so
that's one and well the other thing that they're gonna be doing is source data
verification / source data review and that has to be done on-site now also for
paper source and you know they're they are thinking about coming out with a
source electronic source which can be done remotely but of course that takes a
while to implement in clinical trials but a serious don't have to go on-site
for IP accountability but basically source data verification source data
review is the CRA is gonna go on-site they're gonna look at the source data
which can be any paper or any kind of forms any kind of diary that the patient
has filled out anything with patient information on it is gonna be sort of
data and they're gonna look at the source data and then compare that /
match it to what's in the EDC which is what the study coordinator is gonna put
into the system that can be that can be viewed online so they're gonna match it
make sure that things are being entered appropriately so just kind of a
double-check on the study coordinator or whoever is entering in that data that it
matches so that's something that you know in the future I'm sure will be done
remotely you'll have an in-house CRA or remote CRA do it or even a computer do
it if it's if it's in there the computer should be able to tell you what's what's
missing and issue queries based on that but we're a while away from that it
seems so CRA is gonna go on site for that and then another thing that the CRA
is gonna go on-site for is just to build rapport with the site staff a lot of
times when you're doing clinical trials you're going to be doing you
using the same sites for these studies because they oftentimes have specialty
whether it be Parkinson's whether it be ophthalmology you know what's the same
doctors that are interested in research and it's the same sites that are
interested in doing these studies usually so you want to build rapport
make sure you've got a good working relationship with those people and a
great way for that you know to build that relationship is for sponsors to
send their CRA s and for CEOs to send their C arrays
on-site to build that rapport so those are the main four reasons why C ray is
gonna go on-site and you know everything else is gonna fall on the in-house CRA
obviously the in-house CRA and the CRA work together but the in-house CRA can
do you know many tasks like collect documents remotely in how CRA is gonna
be issuing queries remotely they can do that where the CRA may be talking about
to the site on when they're on site about these queries and helping them go
through them and they can do that in person but the in-house CRA is able to
do that remotely they're gonna go over action items with them they are going to
maybe even have monthly calls with them some in how CRA positions are are not
going to be doing monthly calls with them that's fine others are more
involved and will be doing monthly calls other in how CRA s are doing the
capability to quat to do site qualification business remotely they can
do closed out business remotely and they do those monthly calls also you just
depends the see the CRA job is not an entry-level job contrary to popular
belief no matter how much you know hustle and ambition and how many degrees
you have you're most likely not going to be a CRA without any type of experience
but you can be an in-house CRA some in-house CRA jobs are opening up now
where they don't require as much clinical research experience so stay on
the lookout as we enter into 2019 2020 for in-house CRA positions opening up to
people with little or no experience I got my first in-house er a gig I had
experience I had over a year of experience for those of you that know I
was on the project management side of things and I moved over to the in-house
side of things now I moved on to CRA but one of the one
of the things about that is you know the in-house role is is entry-level
sometimes but sometimes not in the fields kind of weird with that but it
looks like they're now making an entry level because like I said before they
can do a lot of the things that the CRA doesn't have to worry about when they go
on-site in how CRA can do it remotely like collect documents and all those
type of things so the CRA can just focus on doing what they need to do on-site
and that's pretty much it that's the main difference between the in-house CRA
and the field CRA so I think it really helps when you break it down as what
does the CRA do on-site and why do they need to be on-site then how CRA can kind
of do everything else with with the main things being collecting documents
putting them in the TMF you know issuing queries answering action items even even
answering questions about the protocol from the site the site has a hard time
usually getting in touch with their CRA because the CRA is flying in the air
they could be on site somewhere else may not be as responsive to email may not
pick up the phone which is fine so that's why there's always good to have
an in-house CRA on standby that'ss I can pick up the phone and ask
questions too and I found that even though the CRA in a lot of cases may be
the first contact for the site the see if the CRA doesn't pick up a few times
we're gonna start calling the person that picks up and that's very quickly
they're very quickly gonna find out that's the in-house CRA
so that's that's another big difference I mean a lot of people get confused with
in-house in-house doesn't necessarily mean the CRA is in their own house it
just means that they're in the office usually some in-house CRA s do have the
capability to work remotely it can be anywhere from one to five days a week
but in-house just means like in the office or like in their home office and
remote CRA same type of thing but I typically like using the word field CRA
for people that are in the field in traveling that's the traditional monitor
role that everyone it thinks about when they think of CRA a
lot of times when they have job applications out they may say remote CRA
but really what they mean is that they're not tied to an office they can
live anywhere in whatever region they're hiring for remote CRA but they also
refer to remote CRA s as in house CRA s that don't travel so it can be kind of
confusing to keep that to keep that simple ask questions down below if you
guys got any questions hopefully this video made some sense and thank you for
the person that put this in the comment section and hope this answered you
please put any follow-up questions you may have in the comment section as
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