Senior Informed Consent Specialist

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Spearhead the development and management of informed consent strategies and documentation for intricate, global clinical trials.

• Assume responsibility for scientific operations deliverables, leveraging expertise to tackle complex challenges.

• Direct the formulation, review, and enhancement of global and country-specific informed consent forms for complex or high-risk studies.

• Provide guidance to study teams on informed consent strategies, encompassing readability, cultural nuances, and local regulatory requirements.

• Manage translation, localization, and version control processes to guarantee consistency and traceability across different regions.

• Engage with sponsors, ethics committees, and regulatory authorities to resolve consent-related inquiries and negotiate wording.

• Create guidance documents, templates, and training materials to promote standardization and best practices within the informed consent function.

• Mentor junior informed consent specialists and actively contribute to continuous improvement initiatives.

⛳️ Requirements

• Bachelor's degree in a pertinent scientific discipline or healthcare-related field.

• Extensive experience in clinical research, regulatory affairs, ethics, or a related field with a strong emphasis on informed consent.

• Comprehensive understanding of GCP, ethical principles, and global regulatory requirements for participant information and consent.

• Outstanding writing and editing abilities, capable of producing clear, patient-friendly documents.

• Strong stakeholder management skills, with experience in liaising with sponsors, IRBs/ECs, and cross-functional teams.

• Demonstrated ability to manage multiple complex studies and deadlines while maintaining a high level of accuracy and ownership.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and resources for wellbeing.

• Opportunities for learning and development through structured training and career pathways.