CCG Clinical Operations, LLC

Professional Experience

Clinical Operations Consultant

Senior Clinical Research Associate

Project Manager

Risk-Based Monitor

Global CTM

Study Start-Up (SSU) / Activation Lead

Therapeutic Areas

Oncology
Hematologic Malignancy
(HCT, Cell Therapy, GvHD, MMUD)
2024-2026		Remote and Onsite Monitor (Sr. CRA)
Phases I and II
Platform Design
Endocrinology
T1DM
2026		Project Manager
Phase II
Infectious Diseases
Influenza, HIV, RSV, COVID-19
2013 – 2023		Monitor and PM
Phases II – IV
RCTs, GCP and GLP
Endocrinology
T2DM
2022-2023		PM and SSU Lead
Phase III
Mental Health
ADHD
2016-2018		Risk-Based Monitor
Phase IV
Pediatric

Software

  • Project and Study Management
    • Asana
    • Jira
    • Smartsheet
    • Veeva Project Vault
    • Veeva Clinical (CTMS)
    • Oracle Siebel Clinical Trial Management System (CTMS)
  • Trial Master File (TMF)
    • Florence
    • Veeva Vault TMF
    • SharePoint
  • Electronic Data Capture (EDC)
    • Veeva Vault EDC
    • Medidata RAVE EDC
    • OpenClinica
    • Oracle InForm
  • Randomization and Investigational Product
    • Veeva Vault Randomization and Trial Supply Management (RTSM)
    • Bracket Interactive Response Technology (IRT)
    • Signant Health IRT