Document Review Specialist I

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