Sr Study Start Up Associate
About the role
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Study start up associates are integral in ensuring that clinical
research sites are prepared and have the necessary tools and approvals needed
to start the trial of investigational, new pharmaceutical and biological products
for clinical trials.
As a Study Start up Associate you
will be responsible for the independent preparation, review and approval of
country-related submission packages in accordance with ICH, GCP and all
applicable regulations, laws and other guidelines. This role is also
responsible for the independent preparation, review and approval of site level
critical documents for investigation drug release in accordance with regulatory
and sponsor requirements. You would also be involved in the site start up
activity for clinical research, investigative sites. You would play an important role in ensuring
clinical sites are ready for the first day that the drug trial begins.
We are looking for someone who has
experience working in a clinical environment and who is responsible to handle a
variety of tasks in a short time frame.
You should have knowledge of how an investigative study is run as well
as regulatory requirements. We prefer
someone with a bachelor’s degree and a clinical background with strong clinical
site management experience. Study start up experience is a plus. Experience collecting and submitting
regulatory documents, reviewing of informed consent forms and submitting them
to institutional review boards, and contract review are desired.
This
an exciting opportunity to work within a fast paced, busy study start up
clinical group for a leading global provider of outsourced development services
to the pharmaceutical, biotechnology and medical device industries. We are a company of 13,500
employees in forty countries globally. We differentiate ourselves by
developing innovative solutions to bring life-saving drugs to market faster and
in a more cost-effective way to foster better patient outcomes. We are a top five clinical research
organization with solid earnings and growth potential. Our belief in excellence is our core value in
all that we do for our sponsor partners and the patients that we serve.
As a company we strive to exceed our customers’ expectations in drug development
solutions.
Other than
working with a great team of smart and energetic people, we also offer a very
competitive salary and benefits package that includes an excellent retirement
plan, health coverage, paid time off, income protection insurance programs, and
staff recognition schemes. We care about our people, since they are the
key to our success. We provide an open and friendly work environment where we
empower people and provide them with opportunities to develop their long term
career. Caring for patients
while enjoying what we do and delivering great results is something we can
achieve if we know we can count on each other and have a clear vision of where
we want to go.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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