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. Study Start-Up is often the first operational
service delivery client teams experience when they work with ICON for the first time. This role defines how you can help ICON to become a market leader in this aspect of
clinical trial delivery by working in partnership with the feasibility, site
identification, and start-up teams to reduce the time it takes to select,
prepare, and initiate study sites to recruit patients in our 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.
You will prepare the regulatory binder, ship investigational product,
ensure that all documentation is ready an available at the site, and make sure
that sites are ready to be activated to enroll their first study patient.
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 and communicating with investigative sites is
preferred. 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.
Increasing competition and regulatory demands
are putting more and more pressure on pharmaceutical companies and medical
device manufacturers to reduce the product development timelines. You can be part of the solution to drive
efficiency and improve results for our partners and ultimately for the
population the investigational product may eventually serve. 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
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.
an equal opportunity employer – Minorities/Females/Disabled/Veterans and
committed to providing a workplace free of any discrimination or harassment.