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I’ve been working here for
4 years and I am the Clinical Trial Manager for the renal cancer
trials coordinated by the MRC Clinical Trials Unit. There are
different aspects to my job – depending upon where the trial is,
and whether it’s in set-up, open to recruitment or closed.
During my time at the MRC Clinical Trials Unit, I’ve been fortunate
to have had experience of working on trials at different
stages.
At the moment I am working
on the SORCE trial which will shortly open to recruitment. My
tasks have included drafting the protocol with the Project team and
clinicians, preparing submissions to regulatory and ethical bodies
in order to allow the trial to run in the UK, helping to secure
funding for the trial, designing the forms which will collect the
clinical data on each patient, preparing patient information
sheets, liaising with the drug companies involved with regards to
the contracts to be drawn up, arranging meetings, dealing with
serious adverse events
and designing a database to ensure good data capture.
Whilst a trial is open I’m
involved in the everyday management of the trial. I act as
the first point of contact for hospitals. This can include
answering queries about a patient’s eligibility to enter a
trial, requests for trial protocols/associated documents and
procedures for centre activation. My tasks also include drug
supply management, arranging and being involved in monthly meetings
with the Trial Management Group, document and version control
management, trial promotion (this involves sending out newsletters,
preparing posters, visits to hospitals to discuss the opening of a
trial, dealing with queries/issues related to the study) and
arranging Investigator meetings.
I’m also involved in the
RE04 trial. This trial closed to recruitment in July 2006 and
is in follow-up. I prepare annual reports to groups such as
the National Cancer Research Institute, Trial Steering Committee
and the RE04 Independent Data Monitoring Committee.
As a trial manager it is
essential that I have excellent communication and organisational
skills. It is helpful that I have cancer knowledge, but this
isn’t essential. Probably the most important skill I have is
that of project management, as I need to be able to work to
timelines and deadlines, be able to delegate work and have good
teamwork skills.
Ideally you need a degree in science to be a trial
manager. I have a BSc in Biochemistry and an MSc in Molecular
Medicine. After completing my Masters course I studied for a
PhD in cancer tumour biology – although you don’t need a PhD to be
a trial manager. Working at the MRC Clinical Trials Unit is my
first job since completing my PhD.
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