
Timeline
About me
IRB Manager at HCA Physician Services Group Graduate Medical Education
Education
Tennessee state university
1986 - 1989Bachelor's degree biology, generalUniversity of california, davis
1989 - 1995Doctor of philosophy - phd immunology
Experience
St. jude children's research hospital
Aug 2004 - Sept 2007Assistant/technical director, clinical researchVanderbilt university medical center
Sept 2007 - now1. Team Leader for the Institutional Biosafety Committee-Human Subjects: manage meetings, committee roster, review processes and committee training. 2. Team Leader for the Vanderbilt Institutional Human Pluripotent Cell Research Oversight Committee: manage meetings, committee roster, review processes3. Conduct random periodic compliance or comprehensive directed audits of ongoing research contingent upon consideration of the IRB requests, policies and applicable federal regulations.4. Provide education for department and research community at Vanderbilt. Responsible for acting as an instructor for in person human subjects protection courses which includes preparing and providing the presentations. 5. Maintains current knowledge of all applicable federal regulations relating to clinical trials/human subjects research (45 CFR 46, 21 CFR Parts 11, 50, 54, 312, and others as needed) Show less
Regulatory Compliance Analyst
Sept 2007 - nowRegulatory Compliance Analyst IV,
Sept 2007 - Feb 2022
Hca healthcare
Dec 2019 - now1. Manages process for Institutional Review Board (IRB) submission and review in support of research and scholarly activity within the HCA Healthcare Graduate Medical Education (GME) program. 2. Maintains accurate IRB files/records and IRB access database, ensuring strictest confidentiality compliance on all IRB matters/records according to HIPAA, HHS, and FDA regulations, and other policies within HCA Healthcare GME network.3. Provides technical support, procedural and regulatory guidance, human subjects research protection education, and training for human subject research protocols to GME residents, faculty, fellows, coordinators, and others in leadership or administrative roles.4. Manages education, membership, training, and meetings, for the HCA Healthcare GME IRB.5. Supervises and manages the performance of IRB software application that is utilized by HCA Healthcare GM E network.6. Supports GME resident investigators as they progress through various aspects of IRB review/approval processes. Show less
IRB Manager HCA Physician Services Group Graduate Medical Education
Dec 2019 - nowIRB Manager
Dec 2019 - Feb 2022
Licenses & Certifications
Certified irb professional
Public responsibility in medicine and researchOct 2001
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