Experience

PPD

• United States
• Research Services
• 700 & Above Employee

• Senior CRA

  • Sep 2020 - Present



Self-employed

• Photographer

  • Sep 2019 - Present



Boston University School of Medicine

• Student



Syneos Health (Previously INC Research/inVentiv Health)

• Denver, CO

• CRA II at Syneos Health

  • Jul 2017 - Aug 2020



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• CRA1

  • Apr 2015 - Jul 2017



Outcome

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Site Management Specialist II

  • Jul 2012 - Apr 2015

  Perform on-site initiation visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues Remotely supports physicians, nurses, pharmacists, research coordinators and other healthcare workers in use of the company's internet-based tools (EDC) and in all aspects of post-marketing registry management through phone and email support. Follows established SOPs, GCP (when applicable) and other applicable regulatory requirements in the execution of allactivities. Proactively identifies and escalates or resolves operational project issues and participates in process improvement initiatives as required.