B.S., RPh, RAC, CIP CCRC, CCRP
- Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy (CAGT) Baylor College of Medicine
- Assistant Professor Department of Pediatrics Section of Hematology-Oncology Baylor College of Medicine
Mrs. Bambi Grilley has worked in the area of Clinical Research for over 25 years. She has experience as an Investigational Drug Pharmacist, IRB administrator, IRB member, Regulatory Affairs professional, and in the conduct of clinical trials. She has always worked in the area of oncology and, in addition to that, has worked with cell and gene therapy protocols for over 15 years.
Mrs Grilley provides in-depth regulatory guidance to investigators developing projects involving translational products and assists in the regulatory submissions in support of these projects. She teaches about regulatory affairs and clinical research extensively both within BCM and internationally.
She has overseen the regulatory submissions for over 1,600 clinical research studies, almost half of which are therapeutic. She has assisted in the submission of over 75 investigator initiated INDs with over 110 studies conducted under them. She has prepared and implemented over 100 Standard Operating Procedures for clinical research and has established Quality Assurance and Quality Control programs for the protocols being conducted under her purview. She has developed Data Review Processes for internally initiated studies including the establishment of Data Safety Monitoring Boards (DSMBs) for a select group of studies.
She is currently the Director of Clinical Research and Early Product Development for the Center for Cell and Gene Therapy (CAGT).
B.S., Pharmacy, the University of Texas, Austin, TX
RAC (RAPS) Certification – 2008
CCRA (CCRP) Certification – 1998
CCRC Certification – 1999
CIP Certification – 2000
Selected Member (term starting January 2012), Council for Certification of IRB Professionals (CCIP)
Member, Public Responsibility in Medicine and Research (PRIM&R)
Member, Drug Information Association (DIA)
Member, Society of Clinical Research Associates (SOCRA)
Member, Association of Clinical Research Professionals (ACRP)