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Senior Clinical Research Associate

Employer
ICON Strategic Solutions
Location
Slovakia
Salary
Competitive
Start date
15 May 2023
Closing date
2 Jun 2023

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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 organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center 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.

As a Clinical Research Associate (CRA) will have local responsibility for the delivery of the studies at allocated sites and be an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Leader to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.

ICON is currently recruiting for a CRA II or Senior CRAs in Poland to work on a range of therapeutic areas.

This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

SrCRA with strong experience may take on additional responsibilities that include additional tasks associated with study management.

Responsibilities:
  • You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities both remote and on-site.
  • You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
  • As the CRA you are the main sponsor r epresentative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
  • You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
  • As the first point of contact for study sites, escalating any concerns/issue s to other departments including Safety, Investigationa l Medicinal Product, Local Study Managers and management team as appropriate.
  • Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.


To be successful in the role, you will have:

  • Bachelor’s Degree (or equivalent)
  • Minimum 2 years of independent on-site monitoring experience
  • Ability to travel nationally with overnight stays
  • Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
  • A demonstrated working knowledge of ICH/GCP Guidelines
  • Excellent record-keeping skills and attention to detail
  • Fluent in English and Polish, both written and oral


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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