hey guys ECR G here back with another video today we're gonna be talking about
what is a TM f specialist hey guys ECR G here back with another video today we're
gonna be talking about what is a TM f specialist now this is a position that
has cropped up all over the industry because I'm just gonna be honest with
you guys the TMF is in bad shape all across the
industry it is in terrible shape so this this position is cropping up because
there needs to be a point person on the study who is over the TMF ensuring its
completeness ensuring that it is up to date because it has been in bad shape
for a long time sponsors have been frustrated with it
and this isn't just particular to a specific CRO this is that many CEOs have
a hard time with the TMF because there has not been a point person for it and
it hasn't been maintained throughout the course of the study it's just at the end
of the study by the time the end of the study comes it's time to deliver the TMF
to the sponsor and it's all out of whack and they got to spend a lot of time and
money and effort to get it get everything reconciled and get everything
into the TMF so this is a new position that companies are hoping will save a
lot of money and a lot of stress at the end of the study in order to keep the
TMF up to date during the study so this video really
comes from someone who is going to do an interview for this position soon and
they wanted me to kind of break it down what is a team of specialists why is it
a good position to get into especially if you're new to clinical research and
you know what is really the TMS specialist now full disclosure I've
never been a TMF specialist before I have worked with people in the TMF
department but I myself have never been a TMS specialist or really in that
friendly with someone in the TMF department but I have been
offer these type of positions before people on LinkedIn have hit me up with
these positions before so I am somewhat familiar with the role and definitely I
understand completely having been in the project management
sphere for a while why the TMS specialist role is important like I said
before this is a good role for entry-level personnel because you are
gonna get access to a lot of the documents you know the essential
documents monitoring reports you're gonna touch all of the documents that go
into the TMS 1572 s protocol signature pages the actual protocol you know you
name it financial disclosure forms medical license CVS the documents go on
and on you're gonna get access to all these documents you're gonna see them
because you're gonna be the person putting them in there so this is a great
role for entry-level people for that matter because you're gonna get access
to all the documents and be able to see them now before we get into this role a
little bit further I'd like to discuss since this is an entry-level role you
may have trouble getting into the industry because typically industry
personnel want people that have previous experience or they want people that have
had you know experience with the data or with this experience with the TMF or
something like that so maybe hard getting into the industry and we've got
something for you we've got a resume review program the
resume review program is you send your resume in to us we go over it we comb
through it we update it we strengthen it we insert clinical research terms we
basically translate your experience into clinical research related experience and
that's gonna help you get around the algorithm when you apply for jobs is
going to help you have a leg up on other candidates that are applying from
outside fields or have no experience when applying for clinical research
positions so if you're interested in that email us that elite clinical group
at gmail.com so what else does a TMF specialist do now this is a very
specialized role because all they're going to be touching is the TMF but it's
very important the TMF is the most important deliverer
that's delivered to the sponsor at the end of the study it is the most
important deliverable now you might be asking if it's so important why was it
all away whack all these years why was a TMS specialist even needed before if
it's so important and that's typically because like I mentioned earlier it's
not really a priority for monitors when monitors collect these documents they
are you know stuffed in their backpack maybe they're not scanned into their
computers yet when remote monitors collect these documents you know it's
not really a priority they have so many other monitoring calls to do monitoring
business to do it's not really a priority to send these documents into
the TMF so the end of the study comes and they realize all these documents are
missing so you know you got to reach out to this site get reach out to these
monitors who have turned over probably by the time this study is over they're
probably off at another company heck they could be at another two companies
by then they may have jumped twice there's a lot of turnover in the
clinical research industry so it's hard to get these documents and that's one of
the reasons why I caused so much money at the end of studies to get get a
document and focus on the TMF so pretty much during during the course of the
trial the team of specialists is gonna be responsible for monitoring the health
of the TMF monitoring which documents are needed they're gonna tell the study
team they're gonna tell the study team at the internal meetings which happened
weekly between the project team maybe some some representative of the clinical
team will be there like the LEED CRA and they will talk about okay which
documents would do we need to collect from the site why don't what are people
doing that's good getting those documents in and then
they're pretty much gonna relay the overall health of the TMF to the study
team which is good so they're gonna be able to do that throughout the course of
the study so hopefully by the end most of the documents are in place and
they're really gonna be auditing the TMF they're gonna be assessing internal
quality they're gonna be in close contact with the project manager of
course who is gonna pretty much help oversee the TMF with them you know
they're really just gonna be over the all those documents they're gonna see
all those documents make sure they're named appropriately make sure they're
filed in the same play make sure that you know they're signed
and dated make sure that all the pages are in there like if you just got two
pages of a delegation log but it says that there's three pages they're gonna
go in there and say hey we need to collect that third page even if it's
blank you know they're gonna be over pretty
much the health of the TMF and make sure that it aligns with the sponsor
requirements what the sponsor wants for the TMF so very good role and they're
gonna be that point person so I think this is definitely a good role in
general for study it's very needed because TMF is huge right now in
clinical research it is huge and as you can see that you've seen these roles
start to pop up all over the place these TMF specialist roles so definitely would
recommend but it does kind of pigeonhole you but it's a great way to get your
foot in the door in the clinical research industry let's see if I'm
forgetting anything else nope so you know one of the things they're
also gonna do is to make sure they're gonna try and like proactively look at
what issue issues there could be in the future for the TMF and try and come up
with some scenarios to combat that so pretty much there the team f expert
they've got to know the health of the TMF at all times and they're gonna make
sure that you know the team f stays healthy and documents are collected and
put in there named appropriately like I mentioned earlier so hope you enjoyed
this video if I forgot anything or any questions comment down below I'll
respond to your comments or you can email us at elite clinical group at
gmail.com like I mentioned before resume review again resume review program email
us there also any increase you may have email us there also so like this video
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