hey guys ECR G here and today we're gonna be talking about what is a
clinical research associate or CRA hey guys
ECR G here and today we're talking about what is a clinical research associate or
a CRA as they're often called for short or a monitor a lot of times they're
called monitors but it's the same thing they're synonyms they're talking about
the exact same position now this is the position too everyone always comments
about or everyone knows clinical research for the clinical research
associate this is the position that I guess made clinical research famous and
people want to go into it and why is that that's for a couple of reasons one
people that are younger tend to want to travel more for their job at least in
the beginning you know people that are older may go into things like project
manager or become a clinical trial lead or a lead CRA because they don't have to
travel as much you only got a family that you got a house to take care of but
people that are younger than the millennial generation right now are fine
traveling all the time and quite frankly Clinical Research Associates do a lot of
traveling and they make pretty good money so that's why it's an attractive
option for many younger people but then obviously that's a straight up
generalization there are young people that don't want to travel as much so
they may go into project management and that's fine or they may become an
in-house CRA which is going to do the similar things we're going to talk about
in today's video that a CRA does but just from an in-house perspective so
they'll do that remotely from home or in the office so this is a CRA and I'm sure
a lot of you guys know about what a CRA does at this point but just to review a
little bit what does a CRA do so the purpose of the CRA is to go to each site
on the protocol and ensure that they are following GCP IC h regulations
they want to make sure that the site is in compliance with those regulations as
well that they are in compliance with the protocol and basically to make sure
that they aren't you know taking any shortcuts that patients have been
enrolled and it pretty much ease them along throughout the study make sure
that they're following everything that need to be followed and you know there's
an increased propensity for the for clinical research is going into a more
remote direction and so they're gonna be trying to have C arrays only go out when
you know this is kind of risk based monitoring they're gonna only have them
go out when there's a high risk to make a mistake and or when the data point is
at high risk and that's because you know it takes a lot of money for obvious
reasons you gotta pay for flights and pay for food and all that stuff when you
send someone out each time but as far as it goes right now it's very important
that the CRA goes out you know they're gonna be making sure that the amount of
drug I pee and the amount of IP that is being dispensed to the patient is
actually the amount being dispensed they're gonna be checking the IBRS
system for that they are going to be monitoring case report form the
electronic data for quality completeness and accuracy you know so they're they're
really going to be doing a lot with the data and it's it's an attractive
position for people because it's on the clinical side they're getting hands on
with the people that are actually going to be conducting the research and that's
a that's something to think about if you're interested in going the clinical
route or project management route if you're in project management you're
going to be a little bit distance from people that are conducting the research
so a lot of people like clinical operations for that reason you're going
to be one step closer to the research so that's gonna be the main thing
monitoring case report forms are also going to be issuing and closing out
queries for the research site they are also going to be assisting with the
collection of study documents so the p IC B's the sub I CV is the making sure
that the P I has a GC p training and things like that maybe collecting all
those documents and either scanning them or bringing them back and let me copy
back to the CRO to be put into the TMF so they're going to be doing that now
the CRA may input to the TMF themselves or likely they're gonna be sending it to
someone like a CTA that's a clinical trial assistant or project coordinator
or whoever the CRO has there's gonna be a designated person and often these
these roles have different titles to them these are more entry-level roles
and the CRA is going to be giving it to that person and they're gonna be putting
it into the TMF or the CRA may be putting it into the TMF themselves if
they're a really good CRA they're really good but it's very hard for them to do
it because they're usually very busy and traveling all the time so that's pretty
much it you know Cape case report forms their training the sites on the protocol
in GCP IC h making sure that they're following that at the end of the day
they they do teach the site than me answering their questions on the
protocol because sites are always gonna have questions on the protocol so CR A's
have to really be masters of the protocol really have that down pat make
sure that the doctors and the people doing the research the study
coordinators are following the protocol to the T because if they're not
following the protocol and that's going to be a protocol deviation and that data
point is going to be at risk for not being included in the study so all that
money time and effort that was spent you know for that particular patient could
be null and void if CRA doesn't catch a protocol
you know they're also to be monitoring for adverse events and serious adverse
events if you haven't already you can we're not going to rehash that here but
you can see our video there on adverse events and the difference is there
between that but are we looking out for adverse events and serious adverse
events so that's pretty much it you know one of the reasons why the CRA is get
paid so much is the travel and they're gonna be just on the road constantly
three four days a week I've seen and you know they're busy it just takes it just
takes a lot out of them so a lot of CRA do get burnt out from time to time it
just depends on your support system and you know it if you really enjoy the
lifestyle and CRA s are not entry-level positions if you should go back and
watch our video on why you should be patient to be a CRA about that more
in-depth but see arrays are not entry-level positions the more
entry-level positions if you have no experience with clinical research you're
gonna be looking for like study coordinator clinical trial assistant is
a good one maybe site ID specialist another good
one or a project coordinator or project specialist at some companies and these
are the more entry-level positions to really get yourself acclimated to
clinical research so you should look for that look out for those and then after
you know a year or two of that then you can slide into a clinical research
associate position and then you can just move up from there they have clinical
research associate level 1 level 2 level 3 and then typically after that they'll
have like a lead clinical research associate or a clinical trial lead same
similar role just different titles a different companies just depends and the
lead or the clinical trial lead is not gonna be traveling as much as a CRA so
you know that that's fine that's that's up to them but that just typically how
the ranking system goes and as far as the sponsor goes each CRA have to be
queered by the sponsor so each seer each CRA have to be allowed
by the sponsor to participate on that study so it's a lot easier typically
they want to spend more more money and get a C or a two or C or a three to come
on their study because they are obviously going to know more about you
know being a CRA they're gonna know how to typically you know do all the things
that our series going to do they're more experienced so they're gonna do things
faster than an entry-level CRA is you know a level one who it doesn't have as
much experience so it can be difficult at first when you become a CRA one to
get experience on trial because you have to be cleared by the sponsor still it's
it's not like you're home free once you become a CRA you still gotta put in the
work and get cleared by the sponsor which we which can be difficult but you
know just takes time like everything so a lot of people wants to become a CRA
there they're either waiting around you know just doing TMF well you know you
gotta wait for that right protocol in order to be trained or wait for someone
to take you under their wing in order for you to be trained appropriately so
that's a little bit about what is a clinical research associate or CRA or
monitor you know I outlined a few points there about a few major things that they
do so if I missed anything you see arrays that follow the channel
please comment down below any key things I may have missed I think I get all the
big ones but this in case I miss they think he's coming down below like this
video share this video comment down below also you can email us at elite
clinical group at gmail.com all you see are a is out there if you want to be
interviewed we'd love to hear what you've got to say about what it's like
being a CRA we can keep it anonymous we can you know just do audio only so if
that's what you want we won't talk about where you work
like that so email us at elite clinical booth at gmail.com or comment down below
and that's pretty much it for this video guys take care
you