GCP Auditor / Senior CRA

After 17 years in clinical research, mainly as a project manager and CRA in biotech companies and CROs, I have decided to start a new career as a freelance GCP Auditor/senior CRA. I was certified in November 2018 by Barnett International and I have conducted a few GCP investigational site and GcLP co-audits so far. Barnett International delivers a training which is FDA and BIMO inspections-focused.

When creating my own company San.K.Bio Consulting, I developed robust auditing techniques and tools, based on my experience in clinical research and on my Auditor training. My biggest assets are my strong knowledge of both European and FDA regulations, and the variety of my experience in clinical trials. Since the beginning of my career, I have also been actively involved in Quality Assurance, writing SOP, managing and reviewing CAPAs. Detailed-oriented, I have always had high standards in my work and improved the quality of the projects with which I have been involved.

My company San.K.Bio Consulting also provides monitoring services and essential documents review. I have been monitoring clinical studies in various countries of the world (France, Spain, Portugal, Mexico, USA) and my high communication skills enables me to rapidly adapt to any new project. My experience as a lead CRA and project manager made me understand the larger context of the monitoring effort. I have more than 14 years’ experience in visit reports’ review written by CRAs from worldwide, and I can perform a thorough review of your CRAs’ monitoring reports, ensuring they deliver a high quality final report, that will give an accurate and clear picture on how the clinical study is handled at the site. Finally, since I have been involved in writing and review of thousands of essential documents since the beginning of my career, I can give a take a fresh look at your documents and bring a critical eye on protocols, CRFs, ICFs, subjects facing documents etc.