Informed Consent Specialist II

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As an Informed Consent Specialist II at ICON, you will independently manage informed consent activities across clinical studies, ensuring documents are compliant, patient-focused, and aligned with regulatory, ethical, and sponsor requirements. You will collaborate with cross-functional teams, provide guidance on informed consent processes, and contribute to continuous improvement initiatives that support quality and efficiency.

What You Will Do:

You will take ownership of informed consent deliverables across multiple clinical research projects, applying your expertise to ensure accuracy, compliance, and operational excellence.

Key responsibilities include:

• Independently preparing, reviewing, and managing informed consent forms (ICFs) and related participant-facing documents in accordance with study protocols, regulations, and sponsor requirements.
• Coordinating informed consent activities across multiple studies, ensuring timelines, quality standards, and deliverables are met.
• Managing ethics committee and regulatory submission activities related to informed consent documents, including approval tracking and issue resolution.
• Overseeing consent templates, translations, version control, and document updates across countries and sites to ensure consistency and compliance.
• Serving as a key point of contact for internal stakeholders, providing guidance on informed consent language, requirements, and document processes.
• Identifying and resolving document discrepancies, compliance risks, and process issues with minimal supervision.
• Ensuring accurate filing, maintenance, and documentation of informed consent materials to support audit and inspection readiness.
• Contributing to the development of process improvements, best practices, templates, and standardization initiatives within the informed consent function.
• Supporting the onboarding, training, and day-to-day guidance of less experienced team members as needed.

Your Profile:

You will bring clinical research experience and a strong understanding of informed consent processes, along with the ability to manage multiple priorities in a dynamic and highly regulated environment.

Required qualifications and experience:

• Bachelor's degree in life sciences, healthcare, legal studies, or a related field, or equivalent experience.
• Experience in clinical research, regulatory affairs, ethics submissions, informed consent management, or a related discipline.
• Good understanding of informed consent principles, ICH-GCP, ethical requirements, and applicable regulatory guidelines governing clinical research.
• Demonstrated ability to independently manage document review processes, timelines, and stakeholder communications.
• Strong attention to detail and organizational skills, with experience managing complex document workflows and competing priorities.
• Effective written and verbal communication skills, with the ability to collaborate across cross-functional and global teams.
• Proficiency with MS Office and experience working with document management systems, workflow tools, and tracking platforms.
• Ability to identify process improvement opportunities and contribute to initiatives that enhance quality, compliance, and efficiency.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply