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Clinical Research Associate

Employer
ICON Strategic Solutions
Location
Germany, Homeworking
Salary
Competitive
Start date
31 Jan 2023
Closing date
8 Feb 2023

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

Working fully embedded within one of our clients in medical devices, with the support of ICON

right behind you, you'll be at the heart of our client's innovation. As Clinical Research Associate,

you will be dedicated to one of our global clients; a well-established company active in Medical

Devices.

As a Clinical Research Associate, you will have the opportunity to experience the full lifecycle

of a project.

Key Responsibilities:

  • Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
  • Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
  • Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
  • Attend all required meetings and provide updates to team.
  • Support EDC user acceptance testing and training as applicable.
  • Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation.


  • Bachelor or Masters in Science or Healthcare discipline.
  • Approximately 5 years related experience in clinical studies (healthcare setting, CRO, medical device and/or pharmaceutical company and/or industry).
  • At least 3 years of experience as a Clinical Research Associate monitoring clinical studies
  • Experience in using EDC and CTMS systems is desirable.
  • Experience with direct line management of staff including hiring, training, oversight and mentoring.
  • Good command of written and spoken English language.
  • Excellent verbal and written communications skills.
  • A demonstrated working knowledge of GCP, ICH guidelines, ISO Standards, FDA/EU regulations.
  • Ability to work very accurate and thorough.
  • Excellent record-keeping skills; good documentation practice.
  • Flexibility in work hours and readiness to travel.


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 development.

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.

Company

As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.

ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.

Why choose a career with ICON Strategic Solutions?

Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.

Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.

Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.

Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.

Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.

Company info
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