✍️ Advance Ethical Research as an Informed Consent Form (ICF) Specialist
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as an Informed Consent Form (ICF) Specialist. In this crucial role, you'll ensure the ethical integrity and regulatory compliance of clinical trials through expert ICF development and review, directly contributing to patient safety and research excellence.
🎯 Your Impact: Key Responsibilities
ICF Development & Excellence
- Develop, review, and approve Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for:
- Global master templates
- Country-specific versions
- Site-specific adaptations
- Ensure all ICF documents maintain accuracy, clarity, and compliance
Regulatory Compliance & Quality
- Apply expert knowledge of ICON SOPs/WPs and ICH/GCP guidelines
- Ensure compliance with applicable country regulations for Informed Consent
- Maintain accuracy and completeness of ICF documents in Trial Master File (TMF)
- Represent the department during audits, inspections, and committee work
Stakeholder Collaboration & Leadership
- Serve as key contact for Sponsors, SSU Project Managers, and Clinical Trial Managers
- Review, negotiate, and approve Ethics Committee and regulatory authority queries
- Act as Subject Matter Expert (SME) for assigned topics
- Develop and conduct training on ICF requirements and best practices
Project Management & Risk Mitigation
- Forecast and track SIS & ICF approval timelines
- Proactively identify risks and develop contingency plans
- Mentor and coach new hires during onboarding
- Optimize performance to ensure successful project outcomes
⭐ Your Profile: Qualifications & Experience
Essential Requirements
- Minimum 2 years of direct experience in ICF writing and development
- Strong English writing and communication skills
- Proficient knowledge of ICH/GCP guidelines and country-specific regulations
- Experience with Ethics Committee and regulatory authority interactions
Technical Competencies
- Protocol interpretation and review (preferred)
- Understanding of clinical trial documentation requirements
- Knowledge of regulatory submission processes
- Familiarity with Trial Master File (TMF) requirements
Professional Attributes
- Excellent analytical and problem-solving skills
- Strong attention to detail and accuracy
- Ability to work collaboratively in team environments
- Effective communication with diverse stakeholders
- Proactive risk identification and management
💫 Why Join ICON plc?
Global Impact & Purpose
- Contribute to ethical clinical research that advances global healthcare
- Work with a world-leading clinical research organization
- Play a crucial role in protecting patient rights and safety
- Join an inclusive environment driving innovation and excellence
Career Development & Growth
- Access to comprehensive training and development programs
- Opportunities for professional advancement and specialization
- Work with industry experts and thought leaders
- Clear career progression pathways
Exceptional Benefits & Well-being
- Competitive salary and comprehensive benefits package
- Range of health insurance options for you and your family
- Global Employee Assistance Programme with 24/7 support
- Flexible working arrangements and work-life balance focus
Additional Benefits
- Various annual leave entitlements
- Competitive retirement planning options
- Life assurance coverage
- Country-specific benefits including:
- Childcare vouchers
- Gym membership discounts
- Health assessments
- Travel passes
✨ Ready to Shape the Future of Ethical Clinical Research?
If you're an ICF professional with 2+ years of experience and passion for ensuring ethical research conduct, we encourage you to apply. This role offers the perfect opportunity to advance your career while making a meaningful impact on global clinical development.
Apply Now & Become Our Next ICF Specialist!
ICON is committed to inclusion and belonging, providing an inclusive and accessible environment for all candidates. We encourage applications from all qualified individuals, regardless of background or experience level.
