# ICF Specialist

**Company**: ICON Strategic Solutions
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/UK-Reading/ICF-Specialist_JR162222?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_deaf106b-ed8

## Description

As an ICF Specialist at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

You will take a lead role in the development, review, and oversight of informed consent documents for complex, global clinical trials within a growing, global Biotechnology company.

**Key Responsibilities:**

- Review and manage global, country-specific, and site-level ICFs to ensure 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 necessary.

- 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 needed.

**Requirements:**

- Minimum of two years of experience working with Informed Consent Forms.

- 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 information into clear, patient-friendly language.

- Self-motivated, detail-oriented, and able to manage multiple tasks simultaneously.

- Proficiency with Microsoft Office applications.

- Good interpersonal skills and comfort with ambiguity.

**Rewards & Benefits:**

- Competitive base salary and performance-related incentives.

- Health and wellbeing programs, including medical, dental, and vision coverage.

- Retirement and pension plans.

- Life assurance and disability coverage.

- Employee assistance programs and wellbeing resources.

- Learning and development opportunities.

## Skills

### Required
- Informed Consent Forms
- ICH-GCP
- FDA
- EU CTR
- Microsoft Office
- writing
- editing

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