Experience

Medelis, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Product Safety Associate / CRA Manager

  • Aug 2018 - Present

  • Ensure timely reporting of initial and follow up notifications of serious adverse events (SAEs) to sponsors according to applicable FDA regulations, GCP and ICH guidelines and applicable SOPs.• Review SAE reports to ensure quality data entry and narrative information based on source documents submitted.• Use SAE databases (ARGUS).• Write CIOMS /MedWatch reports for regulatory submission.• Establish and maintain collaborative working relationships with associated groups, such as clinical monitoring, project management, regulatory affairs, etc.• Hire and oversee contracted CRAs. Review expense reports and invoicing.• Perform site qualification, site initiation, interim monitoring, remote monitoring and site closure visits.• Maintenance of Trial Master Files• Participate in business development activities



IQVIA

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

• CRA

  • Apr 2016 - Aug 2018



Sarah Cannon Research Institute

• United States
• Research Services
• 400 - 500 Employee

• Strategic Site Manager

  • Feb 2007 - Apr 2016

  • Responsible for the overall Clinical Research program for a Community Oncology Practice of four clinics and 16 physicians.• Oversaw conduct of study from initial lead through study close out.• Revised SOPs and developed Working Process Guidelines to bring site to audit readiness.• Developed orientation program, skills and competencies, job descriptions.• Staff education regarding new regulations, processes and quality assurance programs.• Marketed research program and services to community.• Increased enrolling protocol menu two-fold• Managed budget from a deficit to profit over three yrs.



Vanderbilt University Medical Center

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

• Research Nurse

  • Jan 2003 - Jan 2007