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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