Informed Consent Writer

Job Summary

A company is looking for an Informed Consent Writer responsible for preparing informed consent documents for clinical trials.

Key Responsibilities

• Read and understand protocol-specific design, objectives, and study procedures
• Prepare study-specific informed consent documents using established templates and required risk language
• Manage informed consent writing projects and participate in clinical trial team meetings to ensure timely delivery of documents

Required Qualifications and Education

• Life sciences degree
• 3-5 years of relevant experience preferred, including experience translating scientific material for a lay audience
• Understanding of clinical trial operations and informed consent forms
• Technical expertise in MS Office and document management systems
• Knowledge of International Council on Harmonization (ICH) and regulatory guidance pertaining to informed consent