hey guys II see RG here today we're gonna be talking about CRA skills
lacking in critical areas
hey guys ECR G here back with another video today we're gonna be talking about
CRA skills lacking in critical areas there was an article that came out
recently titled this and to be honest with you I wasn't even going to record a
video today an episode if you're listening on the podcast but this
article came across my phone on linked-in and I found it really
interesting so I wanted to discuss it with you guys maybe you guys are
interested in becoming CRA s and are wondering how can I be a CRA why is it
so hard to be a CRA and I think this article provides some insight into that
particularly because we've done a video in the past about a company or
organization title IA OCR and we talked about how their new initiative is to
rate CRA s based on competency and not on years of experience so sponsors
typically want two years of experience before you can monitor on their trials
before you can become a CRA and they definitely hire series with more years
of experience but ia international I think internet something IAS er is and
is that has found out that it is not the years of experience that correlate with
competency people you know regardless of how many years of experience they have
can be competent enough to become CRA s and that is what we should be looking
for and this study and this article actually found out the same thing that
regardless of experience determines how good you are at being a CRA so basically
this group they are CRA a let's see what that stands for
they have a simulation that's called but yeah they're companies called CRA
assessments so CR AAA and they have a simulation that they
were to determine how you are at monitor and
they basically ran this simulation and basically what they did methodology wise
is they consisted of assessments conducted on 579 unique C arrays all
over the world North America Europe the Middle East Africa Latin America and
Asia Pacific and they collected more data on basically the CRA s title
so one two three senior how many years of experience they have number of
monitoring notes time to complete the simulation and the scores that they got
from this is from the assessment from the simulation that was administered so
they were monitored on eight different categories the ICF process informed
consent process IRB IEC reporting protocol requirements IRB IEC submission
and approvals source documentation source to EDC potential fraud and
delegation of authority in this C so of the 579 samples 233 were from North
America 225 were from EMA I think that's Latin America 79 from Asia Pacific Oh
eeeh EMEA is where yummy Oh Europe and Middle East it's 42 is from Latin
America all right so that's basically it so they had 282 where senior CRA 78 or
CRA twos and 69 or CRA ones and then they basically had an average score so
basically I'm gonna just quickly go through the results here so they showed
that sea Ray's exhibited similar average scores regardless of CRA title
so CRA ones had assessment scores averaged 64% CRA twos averaged 59% and
senior CRA is average of 60% so when they found out they found that the
series altogether perform the best in the ICF process protocol requirement in
delegation of authority scores tended to be lower in higher B IEC reporting IRB
iuc submission approval and source documentation and source 2 EDC domains
and then the potential fraud was the lowest domain by far of all eight
domains so apparently CRA s are not good at detecting fraud then let's see so
yeah here in the discussion this is what they say this is the sentence that
really got me the analysis reveals first and foremost that CRA average competency
scores were near equivalent regardless of CRA title when administered in the
simulation and then they also found there was wide variability within the
domains all domains had at least one serious score that was a hundred percent
whereas seven of eight domains had at least one CRA with a zero percent and
then they have found that there were differences among region with Latin
Americans performing the best followed by Europe and Middle East then followed
by Asia Pacific then followed by North America Wow North America performed the
worst so that's interesting so they also found also that see arrays are generally
underperforming in areas critical to clinical trial data quality and
integrity the overall average of sixty percent across all see arrays should not
be acceptable in the global pharmaceutical industry so that's in a
string so series are underperforming and that's probably what they're talking
about in this article and then the previous video I've done on IAO CR is
hey it doesn't matter how many years of experience you have it matters how much
competency you have that's what we should be looking at how good are you as
a CRA and I think it's funny because there's a lot of turnover in the
industry and I think a lot of people have been getting promotions when they
shouldn't have been getting promoted just because of supply the main
economics and hey I am all for supply demand economics I'm all for employees
having the leverage especially when employees have the leverage in the
situation so I'm not complaining at all and I hope it stays that way but it just
it just goes to show that one they should be hiring more Seri ones because
clearly CRA ones are able to do just as good of a job as people with more
experience and CRA twos but it's so hard to get in as a CRA one I know because
I've been through it it's so hard to get in as an entry-level CRA but it
shouldn't matter because clearly the numbers show that they're relatively
equal and you can pay CRA ones less than you have to pay senior CRA s so they
should really take a liking to that CEOs and sponsors but I'm gonna say here yet
so clearly that's a--that's a big deal where you know they all basically scored
the same and I think the sponsors typically thought that more experience
you had the better you're gonna score or the better Seri you were gonna be not
the case but oh yeah I was I was talking about the people jumping around so
they've been getting promotions when they shouldn't have been so someone with
the senior CRA they say they have was say four years experience or they had
that title but really they only have a couple years of good monitoring
experience because I'm of the mindset that you know
after you've been doing it a year you have enough to go in or interview
elsewhere and you really rely on that experience I think the vast amount of
growth happens you know within the first year two years where after that it
starts diminishing returns and you only learn but a little bit each year after
that but yeah I think because of the supply-demand people have been able to
rise in the ranks quickly rather than build competency and if you're jumping
around from company to company different systems different learning environment
you're not able to really master the craft because you're constantly changing
your location you're constantly changing maybe studies you're not able to really
delve deep and deal with any of the issues you had because you were able to
just leave the company and lead those issues behind so I think those are a few
reasons why maybe higher level see arrays are lacking competency and if
they stayed around a little bit longer perhaps they wouldn't be lacking as much
competency and they'd be much better at CRA s so I'm sure there's gonna be a
stay that comes out that shows hey see arrays that stay in the same position
for longer than a year are fare better than the ones that have jumped around so
that's interesting yeah so this article was on apply to clinical trials that's
one of the digital things and I'm sure we're gonna see a lot more articles on
CRA competency I thought this one was really interesting and wanted to share
with you guys especially because a lot of people I know want to become CRA s so
obviously if you're new to clinical research want to get into the field you
want to be a CRA one of the things you gotta have is a really good resume so
obviously email us Ally clinical group at gmail.com we review resumes guys
we've helped a lot of people a lot of people have that good opportunity that
they want get interviews get into the field and it all starts with your resume
so email us at elite clinical group at gmail.com as always
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