those your specialty and oncology or do you monitor things so my specialty right
now is in medical device where I'm working right now yes so where I was CRO
wise as a study manager I was in endocrine studies which were both
therapeutic and device and then at the site level when I was a CRC or clinical
research coordinator I did oncology and non oncology both drug and device and
more recently I made the switch to a sponsor level who has pretty much only
device studies going on okay which do you like better
um I have to say I really enjoy device but I also really do miss learning about
the cutting edge medications that are coming out I think it's just a balance
if you um you have to kind of pick and choose I've never really worked with a
CRA that did both drug and device so I think it's kind of dependent upon what
works best for you at this time because I just started device I can't say much
but I I think that both you learn a lot from you know you learn the regulatory
is very different for device than it is for job and so there's added benefit of
of learning that side of things if you haven't really done any work in the
device industry yeah I mean I've seen a lot of jobs for hiring for medical
device and they specifically want people with you know a few years of medical
device experience so it definitely seems like a very different thing and yeah
definitely at the Cyrano's that I know they had there
unit the CRO that I work for - they have their own unit dedicated to devices so
that's cool
all right so switching gears now - yeah how long were you a study coordinator
for um so I was a study coordinator for about a year and five months so you're
in half almost yep I'd more recently made the switch and so you mentioned
before so you've been at the site level you've been at the CRO level and I guess
you've recently been at the sponsor level as well what what level do you
like the best and can you describe a little bit to the listeners like I guess
what the difference is between the different levels because a lot of people
are brand-new to clinical research and don't really know much like I've never
had any experience so right so I would say that the I I would have to say I
think I really enjoy being on the sponsor level I guess it depends on
which sponsor you work for it because the sponsor I work for it doesn't use a
CRO to run that studies just I'm directly working under the sponsor a lot
of CRH work under the CRO and then the CRO is basically what gets contracted
the CRO and the sponsor have a contract in the CRH represent the sponsor studies
so I really enjoyed being on the sponsor side because you really get to see the
ins and outs of the protocol development and you get to work with the people who
directly are making these devices the engineers you get to work with the you
know principal scientists you get to work with everyone directly the CRO is
basically an organization that the sponsor contracts to do a lot of the
work if they don't have the in-house manpower to do to do monitoring or site
management and all of those things I enjoyed doing that as well but
I think that I would still pick the sponsor level and basically as a site I
really enjoyed doing that short term I don't think that I would ever have
stayed there long term I think a year and a half was enough for me to really
learn everything and I think that's true if you so a lot of people have asked me
this who are interested into getting more experience how long do you have to
be a coordinator to really be a good coordinator and I think that if you work
really hard you just need about a year and a half yeah I think that's probably
safe for a lot of positions in clinical research at least like the ones you can
get your foot in the door on right I remember my manager told me for my first
position she said I was going to take a year before I would feel like really
comfortable that I was like no way is it gonna take a year but she was right yeah
she was bright yeah and okay and then so that's actually really cool that your
sponsor actually runs the trials as well could you know being on the CEO side you
gotta ask the sponsor for everything I wasn't you know there the final say-so
and everything you know you got to direct all that mail and attention to
them and then relay that to the rest of the CRO team and then relay that again
to the sites and so I'm sure that's pretty cool having everything kind of
in-house on the sponsor side and probably makes decisions go by faster
right yes definitely so I remember when I was on the CRO side there was a lot of
back-and-forth you know you would have weekly meetings with the sponsor and the
sponsor you know if you asked any questions the sponsor would have to have
their own internal meeting to send you the information of about their decisions
then we would get that information and then you would have an internal meeting
with all of your team and then make a decision about how to approach do you
have to go back to the sponsor and say something needs to be tweaked or are we
all set to you know relay the information at this site and then you
would go to the sites and then you know from there the sites may push back on a
new you know decision or they may agree but a lot of internal meetings
separately instead of everyone being together on a sponsor level it's not
like that if there's a question or a clarification needs to be sent to these
sides it's pretty quick you know it doesn't take that long because everyone
is pretty much in-house on the sponsor side there's you know there's three CRA
s that are helping out with the study one that travels for the study and then
the others they kind of do some of the extra work that needs to be done and
then everyone is very accessible so that's one benefit of working with the
sponsor as a CRA yep so for every study there is one CRA that does the traveling
so it could be you know if there's five sites then you handle the five sites for
the study and everyone takes you know depending on the study a different CRA
is appointed to do the traveling so it it is beneficial because you get to
really focus on particular studies instead of being spread thin which is
helpful yeah okay so are you doing this are you the traveling soon ready for
that for these protocols yeah or yep yep so for right now so I've been there for
about a month now and I'm now on four studies and I will be traveling for all
four studies oh wow and then okay so you're not going to be
doing any I guess the other people are like in how series they kind of do this
yeah so they do so my position is up to 50% travel which is actually not bad
compared to other entry-level CRA positions which you will very easily see
you know 75 80 % I'm depending on where you work for I really liked a 50 percent
because I get to be in-house also you know I get to be in the office that
leads for half of the time again I work I'm the direct contact with
the site so whereas the other series that are considered in-house they pretty
much do a lot of the documentation paperwork for the study but they are not
the primary contact so my day-to-day tasks involve taking care of the sites
and making sure everything is being done correctly okay so do you have to worry
about submitting documents to the TMF or you just collect them so I collect them
and then I file them in our PMF but the in-house is they're the ones who will go
ahead and print them out and then file them in to look because we have a paper
paper version of it as well they they'll file it into that and they kind of help
remind me if there's something that they realize I need when I'm when I'm going
off to the sites so if they realize there's something that needs to be
collected that we had not discussed about collecting before then they serve
as a reminder as well okay cool so do you like that set up I mean I know
you're fairly new in it but as opposed to the CRO I don't see how I don't know
if it's a fair comparison to make us a sponsor is probably a bigger company
than the Sierra was it's a you know apples to apples comparison but do you
like that set up differently because I know Sierra's get frustrated if there's
a bunch of series I kind of like back them up on a study because you know it
can create some confusion for the site like you reach out to especially if a
series on the road you know be contacted often yep so I am the only CRA contact
for the sites they do not I don't think the sites even have the contact
information for the in-house series so really any site issues have to be relate
to me the other contact is the project manager so if for whatever reason I'm on
vacation they don't go to another CRA go to the project manager and ask a
question yep so that way you know with three CRA
s or for whatever amount of series like backing each other up you're right it
can cause a lot of confusion and quite frankly I think that sites get very
frustrated when there's you know a list of CRA s that they can potentially reach
out to when they have an issue and they don't know who the best one to reach out
to is um so the sponsor I work for it tries to make a very transparent that
you know there's one lead CRA and they're the ones that supports you help
you with any issues that you have