Clinical Study ICF Writer

Job Summary

Working remotely on a full-time basis, the Clinical Study ICF Writer will develop and review Informed Consent Forms (ICFs), ensure compliance with regulatory requirements, and mentor lower-level staff in document review processes.

Key responsibilities

• Develop and review initial and amended Core Informed Consent Forms (ICFs) for compliance with sponsor and regulatory requirements
• Liaise with local teams and sponsors to ensure timely approval of ICFs to meet submission deadlines
• Act as a mentor for lower-level staff and oversee their document review work

Required qualifications

• University/College degree in life sciences or certification in a related allied health profession
• Expert knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines
• At least 5 years of work experience in clinical research
• Relevant and equivalent experience may be considered in lieu of educational requirements