Bambi Jo Grilley, B.S., RPh, RAC, CIP CCRC, CCRP
Professor
Positions
- Professor
-
Pediatrics-Hem-Onc Clinical Research
ÌÇÐÄÊÓƵ of Medicine
- Director - Clinical Research and early Product Development
-
Center for Cell and Gene Therapy
ÌÇÐÄÊÓƵ of Medicine
- Professor
-
Pediatrics
Cell and Gene Therapy
ÌÇÐÄÊÓƵ of Medicine
Houston, Texas, United States
- Member
-
Dan L Duncan Comprehensive Cancer Center
ÌÇÐÄÊÓƵ of Medicine
Houston, Texas, United States
Education
- BS from University Of Texas At Austin
- 01/1985 - Austin, TX, United States
- Pharmacy
Certifications
- RAC (RAPS)
- CCRA (CCRP)
- CCRC Certification
- CIP Certification
- RPh
- #29048 (10/31/2014 - 10/31/2016)
- Texas Board of Pharmacy
Professional Statement
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 indepth 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 1,500 clinical research studies, almost half of which are therapeutic. She has assisted in the submission of over 70 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.
Mrs Grilley provides indepth 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 1,500 clinical research studies, almost half of which are therapeutic. She has assisted in the submission of over 70 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.
Websites
Selected Publications
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Savoldo B, Ramos CA, Liu E, Mims MP, Keating MJ, Carrum G, Kamble RT, Bollard CM, Gee AP, Mei Z, Liu H, Grilley B, Rooney CM, Heslop HE, Brenner MK, Dotti G. " " J. Clin. Invest.. 2011 May 2; 121 (5) : 1822-6.
Pubmed PMID: . -
Grilley BJ, Trissel LA, Bluml BM. " " Am J Hosp Pharm. 1991 Dec ; 48 (12) : 2616-8.
Pubmed PMID: . -
Grilley BJ, Gee AP. " " Cytotherapy. 2003 ; 5 (3) : 197-207.
Pubmed PMID: . -
Rousseau RF, Biagi E, Dutour A, Yvon ES, Brown MP, Lin T, Mei Z, Grilley B, Popek E, Heslop HE, Gee AP, Krance RA, Popat U, Carrum G, Margolin JF, Brenner MK. " " Blood. 2006 Feb 15; 107 (4) : 1332-41.
Pubmed PMID: .
Memberships
- Council for Certification of IRB Professionals (CCIP)
- Selected Member (term starting J
- 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)
- Member
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