Company: ICON Strategic Solutions
Posted on: January 25, 2023
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organisations. With our patients at the centre of all that we do,
we help to accelerate the development of drugs and devices that
save lives and improve quality of life. Our people are our greatest
strength, are at the core of our culture, and the driving force
behind our success. ICON people have a mission to succeed and a
passion that ensures what we do, we do well.
The remote-based Clinical Trial Associate (CTA) will perform tasks
related to supporting operational strategy, planning, and execution
of clinical studies, supporting the strategy as defined in the
Clinical Development Plan.
+ Provide support for critical day-to-day clinical study
activities, including regulatory inspection readiness, in
accordance with established protocols under the general supervision
of the CTA Manager.
+ Collaborate with Clinical Operations Manager, study teams, and
Clinical Research Organizations (CROs) to support clinical study
activities as defined by the clinical trial operating mode
+ Perform departmental tasks as needed.
+ Perform developmental tasks as appropriate with oversight of CTA
+ For assigned complex, accelerated, and/or business critical
studies, provide support to focus on study start-up and site
initiation activities, including but not limited to:
+ Review and/or approval of study documentation, including
essential document packets, study plans, informed consent forms,
+ Supporting oversight of risk-based monitoring
+ Attendance of key team meetings as required.
+ Supporting regulatory inspection readiness (e.g. preparation of
materials and/or participation during regulatory inspections.)
+ Support Clinical Trial systems associated activities for assigned
+ Support Vendor Contract Administration
+ Support study close-out activities
+ Requires strong attention to detail in composing and/or
proofreading and/or approving study materials, establishing
priorities, scheduling, and meeting deadlines.
+ Ability to take ownership and manage tasks, as well as
+ Assigned clinical studies may be high complexity and/or high
+ More than one study and/or more than one program may be
+ Interactions with study teams and other colleagues are both local
and remote (in varying locations and timezones).
Bachelor's degree or equivalent international degree required.
+ 2-4 years' experience in pharmaceutical industry, clinical
research organization, or related role.
+ Experience in Phase 2 and 3 studies and global/international
studies is advantageous.
+ Experience working across multiple therapeutic areas (including
oncology) is advantageous.
+ Knowledge in global/regional regulatory and compliance
requirements for clinical research.
+ Demonstrated excellence in task management and cross-functional
+ Excellent communication skills.
+ Excellent teamwork, organizational, interpersonal, and
Fluent business English (oral and written
**Benefits of Working in ICON:**
Our success depends on the knowledge, capabilities and quality of
our people. That's why we are committed to developing our employees
in a continuous learning culture - one where we challenge you with
engaging work and where every experience adds to your professional
At ICON, our focus is to provide you with a comprehensive and
competitive total reward package that comprises, not only an
excellent level of base pay, but also a wide range of variable pay
and recognition programs. In addition, our best in class employee
benefits, supportive policies and wellbeing initiatives are
tailored to support you and your family at all stages of your
career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive
employer and is committed to providing a workplace free of
discrimination and harassment. All qualified applicants will
receive equal consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the application process,
or in order to perform the essential functions of a position,
please let us know.
Keywords: ICON Strategic Solutions, Lincoln , Senior CTA, Other , Lincoln, Nebraska
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