IQVIA – Overland Park, KS – IQVIA Biotech is now hiring Site File Specialist I. BASIC FUNCTIONS: Responsible for the quality and regulatory compliance of Investigator Site Files (ISF) during the file maintenance period of the study. Work with both internal and external teams to assure good communication regarding documentation processing. Assure documents maintained for a study are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements… and procedures set forth by IQVIA Biotech and its clients. A Regional Site File Specialist I will work in conjunction with or under the supervision of a more senior Specialist and/or Manager Level. Site File Specialist may be assigned to support start-up projects, as needed. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Reviews documents received from sites, IRBs/ECs and CRAs to ensure compliance with GCP and IQVIA Biotech’s standard operating procedures from maintenance through close-out phase…