Document Review Specialist I

Job Summary

Reviewing Investigator Packages and Informed Consent Forms, the full-time Document Review Specialist I will ensure compliance with regulatory requirements while working remotely in the US.

Key responsibilities

• Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements
• Evaluate Core/Country/Site Informed Consent Forms for compliance with sponsor and local regulatory requirements
• Assess Patient Recruiting materials to ensure adherence to Good Clinical Practice (GCP) guidelines

Required qualifications

• University/College degree (life science preferred) or relevant certification from an accredited institution
• Fluency in English, both written and verbal
• Strong knowledge of ICH, FDA, IRB/IEC regulations and guidelines
• At least 2 years of work experience in clinical research
• Experience in training lower-level staff