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CRA II

ICON Strategic Solutions

United States

On-site

USD 80,000 - 130,000

Full time

4 days ago
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Job summary

ICON Strategic Solutions seeks a Clinical Research Associate II to oversee clinical research studies, ensuring compliance and data integrity. The role demands onsite monitoring experience and provides an opportunity to engage with diverse stakeholders. A competitive salary, varied benefits, and professional development are offered, fostering an inclusive workplace where all candidates are encouraged to apply.

Benefits

Annual leave entitlements
Health insurance offerings
Competitive retirement planning
Global Employee Assistance Programme
Life assurance
Optional benefits like childcare vouchers

Qualifications

  • Over 18 months of experience monitoring clinical studies independently.
  • Proficiency in GCP and ensuring compliance during audits.
  • Experience in the Medical Device industry preferred.

Responsibilities

  • Monitor clinical research studies from inception to close-out.
  • Train site staff on study protocols.
  • Create monitoring reports and ensure updates in CTMS.

Skills

Clinical Research Monitoring
Data Integrity
Stakeholder Communication
Regulatory Compliance

Education

BS/BA in Scientific discipline
5 years' experience in Clinical Research

Job description

Join to apply for the CRA II role at ICON Strategic Solutions

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Join to apply for the CRA II role at ICON Strategic Solutions

As a CRA II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What You Will Be Doing

  • The Clinical Operations Clinical Research Associate (CRA) is responsible for monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
  • Ensures that assigned site staff are appropriately trained to the study protocol and to ensure study and data integrity in support of a broader Clinical Evidence Strategy.
  • Produces work abiding by applicable Regulatory statutes (such as GCP) and withstanding scrutiny in the event of an audit.
  • Actively interfaces with various internal and external stakeholders including Clinical and Medical Affairs Management and functional teams, internal customers, Regulatory, Legal, CRO/vendor staff, and clinical research staff.
  • Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
  • Responsible for creating monitoring reports and follow-up documentation and ensuring completion of updates in CTMS.

You Are

  • BS/BA in Scientific or relevant discipline OR 5 years' experience in Clinical Research
  • 18+ months experience monitoring clinical studies including independent completion of qualification, training, initiation, interim, and close-out monitoring activities
  • Must have onsite monitoring experience
  • Must be willing to travel 50% of the time
  • Experience in the Medical Device industry is preferred
  • Open to receive guidance and be mentored by more senior staff

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, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Research, Analyst, and Information Technology
  • Industries
    Pharmaceutical Manufacturing

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