Senior Clinical Research Associate
Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: May 12, 2022
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Job Description:
Working at Horizon is more than a job - it's personal. For us,
success is measured by the numbers that matter most - the number of
lives we touch, the number we change and those we work tirelessly
to help save. We're a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we're a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs.
Summary
This in-house, senior clinical research associate (CRA) position is
responsible for assisting the Clinical Operations department with
managing clinical trials, including onsite co-monitoring, as
needed.
Responsibilities:
Participates in the development, execution, completion, and
reporting of clinical trial(s) according to the regulations, on
time and within budget. Assists in drafting study related documents
(protocol, informed consents) Assists in start-up activities of
clinical studies including Investigator Meetings, selection of
trial sites and investigators. Assist in managing CRO's/ FSPs under
the direction of study managers. Attend co-monitoring visits as
needed. Reviews monitoring visit reports from CRO/FSP. Ensures the
management and tracking to timely resolution of deficiencies
identified via monitoring, auditing, project calls and updates or
other sources. Understands and works to a risk-based approach,
prioritizing the safety and welfare of human trial participants.
Writes, reviews, and / or provides input to study plans and
guidelines. Manages trial related materials and vendors, e.g.
investigational product supplies, ancillary supplies, central
laboratories, central IRB, etc. as assigned. Assists with the
electronic trial master file (eTMF) processes including set-up and
QC. Ensures the quality control of critical documents. Collaborates
with CRO/FSP counterpart on an ongoing basis. Performs monitoring
(PSV, SIV, IMV, COV), as needed, of clinical trial(s) in accordance
with company (or other applicable) SOPs, ICH E6 GCP, and other
regulations and guidance as relevant.
Qualifications and Skills Required:
BS/BA degree in related field, preferably with a scientific
background and 4+ years' experience in clinical development and
operations 3-5 years' experience performing in house study support
or on-site monitoring conducting SIVs, IMVs, COVs and/or
co-monitoring experience for IND regulated clinical research
studies Thorough knowledge of ICH-GCP, Food and Drug Administration
(FDA) and European regulations Demonstrated effectiveness in
resolving site management issues of varying complexity Strong
analytical skills Proficient in Microsoft Office Professional
demeanor Self-starter attitude Strong interpersonal skills
Excellent written and verbal communication skills Ability to travel
- potential to be international -as required
Horizon Core Values & Competencies:
Growth
Manages Ambiguity Strategic Mindset Demonstrates Self-awareness
Cultivates Innovation Develops Talent
Accountability
Drives Results Ensures Accountability Decision Quality
Transparency
Courage Collaboration Instills Trust
Horizon requires all U.S. employees to be fully vaccinated, as a
condition of employment, with either Pfizer (fully approved by the
U.S. Food and Drug Administration), Moderna or Johnson & Johnson
(currently granted emergency-use authorization by the FDA). "Fully
vaccinated" is defined as two weeks after your final dose of the
Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide
medical and religious accommodations as required by law.
Horizon Therapeutics plc does not discriminate on the basis of
race, color, religion, gender, sexual orientation, national origin,
age, disability, veteran status, or any other characteristic
protected by law. It is our intention that all qualified
applications are given equal opportunity and that selection
decisions be based on job-related factors. Any individual, who,
because of a disability, needs accommodation or assistance in
completing this application or at any time during the application
process, should contact the Human Resources Department.
Keywords: Horizon Therapeutics, Buffalo Grove , Senior Clinical Research Associate, Healthcare , Buffalo Grove, Illinois
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