Informed Consent Specialist II/Sr

 Posted 8 hours ago
     
⭐ 2-5 years experience
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AI Summary

Responsible for the preparation, review, and management of informed consent forms in compliance with protocols and regulations. Coordinates ethics committee approvals and manages document translations and version control across multiple sites.
Informed Consent Specialist I - Homebased - Colombia and Chile

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 support the development, review, and management of informed consent documents to ensure they are clear, compliant, and patient-focused.

What You Will Do:

You will take responsibility for clinical research deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

  • Responsible for the preparation and review of informed consent forms (ICFs) in accordance with protocols, regulations, and sponsor requirements.

  • Coordinating the collection and tracking of ethics committee and regulatory approvals related to informed consent documents.

  • Supporting the management of consent templates, translations, and version control across countries and sites.

  • Liaising with internal teams to address basic questions and clarifications regarding consent language and requirements.

  • Ensuring accurate filing and documentation of informed consent materials to maintain audit and inspection readiness.

  • Contributing to process improvements and standardization efforts within the informed consent function.

Your Profile:

You will bring relevant clinical research experience, along with the following qualifications and skills.

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, or document management.

  • Broad understanding of informed consent principles, GCP, and ethical requirements.

  • Strong attention to detail and organisational skills, with the ability to manage multiple document versions and timelines.

  • Clear written and verbal communication skills, with a patient-centric approach to document content.

  • Proficiency with MS Office and comfort working with document management systems and trackers.

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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

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