Seasoned clinical research professional with over a decade of research experience from bench research in a Biosafety Level III laboratory through post-market experience with new therapeutics/devices. Expert knowledge of FDA/ICH/GCP with certificates in health law, clinical research, regulatory affairs, and publications related to clinical research compliance. Eight years project management experience in neurosurgical clinical trials with vertically integrated responsibilities including: grant writing, protocol identification, contract/budgeting, regulatory, IRB submission, staff/resident training, supervision of research coordinators, billing and research compliance. Member of several national clinical research committees.