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Job Post Details

CRA II - job post

ICON
3.4 na 5 gwiazdek
zdalnie
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As a CRA (II/Senior) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

As a Clinical Research Associate II/ Senior, you will be dedicated to one of our global Healthcare clients who have a strong legacy of innovation and leading the way within a specialist therapeutic area. They display an ongoing commitment to changing the lives of patients and the accessibility of products in order to change the lives of those that need them.

The CRA is the primary point of contact between site staff and sponsor. This CRA will be responsible for taking leadership of site management for the selection and initiation of sites on behalf of the sponsor, as well as conducting and closing activities of the appointed studies in compliance with local regulations, ICH- GCP, sponsor´s procedures and protocol requirements.

Responsibilities:
  • Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
  • Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
  • Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
  • Identify potential risks and proactively take action to prevent or mitigate
  • Collaborate with Data Management/logistics in resolving queries
  • Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
  • Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
  • Collaborate with and provide oversight of deliverables from vendors locally, if applicable
  • Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
  • Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
  • Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
  • Support audits and inspections at sites and affiliate, as applicable

  • Bachelor or Master’s degree in life sciences or other relevant fields.
  • At least 2 years of experience as a Clinical Research Associate (for CRA II; for Senior level min. 4 years)
  • Therapeutic area knowledge and demonstrating an understanding of diabetes, psychiatric, neurology, cardiology studies or similar is an advantage.
  • Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
  • Strong analytical and communication skills with business, industry understanding and stakeholder management.
  • Fluent in both Polish and English.
  • Valid driver’s license

What ICON can offer you:


Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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