Experience

GI Alliance

• United States
• Hospitals and Health Care
• 300 - 400 Employee

• • Dec 2021 - Present

  Providing hiring, training & guidance to regulatory team & operations teams for 21 research sites in 7 states. Updating Standard Operating Procedures & coordinating regulatory Work Instructions.

• • Nov 2019 - Dec 2021

  -Provided training & guidance to regulatory team for research sites. Was present for and participated in aggressive expansion of research sites from 7 (in TX and LA) to 19 research sites in 5 states. -Wrote regulatory staff work Instructions to ensure Standard Operating Procedures (SOPs) followed and audit ready



Legends

• United States
• Spectator Sports
• 700 & Above Employee

• Bartender

  • 2012 - Present

  Customer service provider to high level clientele in private club bar Customer service provider to high level clientele in private club bar



The Center for Cancer and Blood Disorders

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• • Sep 2018 - Oct 2019

  Managed regulatory affairs for 100+ Phase II-IV oncology trials from pre-selection site surveys and Site Initiation Visits (SIV) through close out. Responsibilities include but not limited to:• Notifying PIs of INDSRs and SUSARs• Updating Clinical Research team of protocol amendments and creating and documenting training practices for amendments• Deviation confirmation and reporting

• • Jan 2016 - Sep 2018

  Worked with Directory of Pharmacy Services to ensure Investigational Product (IP) was stored, prepared, and distributed in accordance with study protocol for primary and satellite research clinics. Maintained inventory and temp logs.Experience with various EDC and RTSM systems. Training certificates available upon request. IP management for 100+ Phase II-IV hematologic & solid tumor oncology trials. Therapeutic indications include but not limited to: • Breast• Genitourinary• Gastrointestinal• Gynecological• Lung Show less