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.