/ http://www.slideshare.net/images/logo.gif / 際際滷Share feed for 際際滷shows by User: MariaShabe https://public.slidesharecdn.com/v2/images/profile-picture.png *Clinical research experience in Pharmaceutical, Biotechnology, Medical Device and CRO *Gap analyses of Site, Sponsor and CRO and quality management systems for clinical research *Global quality requirements and global audits experience *GCP/GLP audits including IVRS, EDC providers, CROs, central IRBs, central laboratories, Phase I units, sponsor system-process audits, clinical investigator sites and business partners. *Clinical Development/Operations quality compliance lead (risk evaluation, process improvement and procedure development in clinical trials conduct *Clinical document audits, e.g. CSRs, TMF, Annual Reports, etc *Vendor Management, CAPA and Risk-Evaluation process developm... http://www.BACRR.org