“At ICON, it's our
People that set us Apart”
Are you passionate about improving the quality of human
life? If so, we invite you to join us in creating a healthier world
tomorrow.
ICON is a global provider of outsourced development
services to the pharmaceutical, biotechnology and medical device industries. We
specialize in the strategic development, management and analysis of programs
that support Clinical Development - from compound selection to Phase I-IV
clinical studies.
We started as a team of 5 members in 1990 & today we
are ranking at top 4 worldwide based on revenue of 2015. Currently we have
12200+ employees across the globe. ICON is a $1.575bn company having its
presence across 89 offices in 37 countries.
Job
Title
: Study start up associate I /II [ multiple positions
]
Reporting
to
: Manager
Type of Employment : Full
Time
Location
: Chennai
Summary:
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.
Key Responsibilities/Qualification/Experience
SSUA Regulatory
submissions
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
includes independent preparation, review and approval of site level essential
documents for investigational 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 will 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.
Qualification: We prefer someone with a bachelor’s degree and a
clinical background with strong clinical site management/ study start up
experience. Experience collecting and submitting regulatory documents and
communicating with investigative sites is preferred.
Experience: 3+ years
SSUA ICD Review
As a Study Start Up Associate
at ICON working as an Informed Consent Form Reviewer your main role would be to
review Informed Consent Forms and negotiate language as needed. You will
assist in the drafting of ICF country templates for the United States and
Canada, which will then be distributed to study sites to make edits depending
on their local IRB requirements and SOPs. You will review and negotiate these
changes and potentially liaise with other stakeholders like the sponsor, legal,
or the clinical team to ensure that changes to the ICF are acceptable.
Qualification: We prefer someone with a bachelor’s degree and a clinical
background in clinical research at a CRO, Pharmaceutical company, study site,
or who has worked in an IRB. Your experience must include performing ICF review
as an essential function of the job.
Experience: 3+ years
Benefit Working with
ICON:
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 pension scheme, private health care, and life
assurance and staff recognition schemes. This varies from country to country so
a dedicated recruiter will discuss this with you at interview stage.
PROCESS
Technical and competency selection:
When you spot an opportunity you’re interested in and
submit an application, one of our Talent Acquisition Specialists will contact
you to evaluate your suitability for this position, as well as for other
openings within the business.
The evaluation will look at your technical skills and
your competencies – for example, delivering excellence.
Interview
After this, we’ll let you know if we’ll be progressing
with your application. If you have been successful at this stage, we will talk
you through a telephone interview. This will then be followed by an interview
with our Hiring Manager, either face to face or by tele-conference.
Offer
If you’re successful, we will notify you with details of
the offer, talk you through our culture and values, answer any questions you
may have – and above all, welcome you to the ICON team.