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Center for Cell and Gene Therapy

Houston, Texas

Center for Cell and Gene Therapy
Center for Cell and Gene Therapy
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Bambi Grilley, RPh, RAC, CIP CCRC, CCRP

Assistant ProfessorBambi Grilley, RPh, RAC, CIP CCRC, CCRP
Department of Pediatrics
Section of Hematology-Oncology
Baylor College of Medicine

Director - Clinical Protocol Research and Regulatory Affairs
Center for Cell and Gene Therapy
Baylor College of Medicine

E-mail: bjgrille@txch.org
Phone: 832-824-3893

Education

B.S. Pharmacy, The University of Texas, Austin, TX

Research Interests

Mrs. Bambi Grilley has worked in the area of Clinical Research for over 20 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 helps investigators develop clinical protocols and the related regulatory documents. She has overseen the regulatory submissions for over 1,500 clinical research studies, almost half of which are therapeutic. The program includes over 69 investigator initiated INDs, with 116 investigator 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 Protocol Research and Regulatory Affairs for Texas Children’s Cancer Center and the Center for Cell and Gene Therapy.

Certifications

RAC (RAPS) Certification - 2008
CCRA (CCRP) Certification - 1998
CCRC Certification - 1999
CIP Certification - 2000

Selected Memberships

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)

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