About this role
ICF Specialist
About the role
ICF Specialist
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Job title - ICF Specialist
Location - Must be based in the UK, Poland, Spain or Bulgaria
Fully sponsor dedicated
Working fully embedded within a growing, global Biotechnology company, you will take a lead role in the development, review, and oversight of informed consent documents for complex, global clinical trials.
What You Will Do:
Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.
Key responsibilities include:
- Review and manage global, country-specific and site-level ICFs, ensuring accuracy, consistency and protocol alignment.
- Assess ICF content for compliance with applicable regulations, ethical standards and participant readability requirements.
- Apply plain language principles to create clear, patient-friendly informed consent documentation.
- Identify and resolve quality, compliance and content issues, escalating risks where appropriate.
- Contribute to the development and continuous improvement of ICF templates, processes and supporting documentation.
- Act as a key point of contact for ICF-related queries and coordinate reviews with internal stakeholders and external partners.
- Track review activities and support reporting on quality and performance metrics.
- Manage multiple priorities and deliver high-quality reviews within study timelines, including urgent requests.
- Adapt to evolving study requirements and provide support in a fast-paced, deadline-driven environment.
- Provide additional support across R&D Budget & Contracts activities and other departmental initiatives as required.
Your Profile:
You will bring relevant clinical research experience, along with the following qualifications and skills.
Required qualifications and experience:
- Minimum of two years working with Informed Consent Forms.
- Preferred knowledge of ICH-GCP, FDA, EU CTR, and other applicable country regulations governing informed consent.
- Excellent writing and editing skills, with the ability to translate complex, technical, or legal information into clear, patient-friendly language.
- Self-starter who works independently, proactively identifies issues, and proposes solutions.
- Detail oriented.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Proficiency with all applications of Microsoft Office.
- Good interpersonal skills.
- Comfort with ambiguity; ability to act without having the total picture
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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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, 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
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Location
Reading, Livingston
Reference: JR162222
Categories
Study Start Up
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ICON Strategic Solutions (FSP)
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Remote
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