Experience

Cidara Therapeutics

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Manager, Quality Assurance (GCP)

  • 2019 - Present



Vical

• United States
• Biotechnology
• 1 - 100 Employee

• Clinical Project Manager

  • 2014 - 2019



Independent Consultant

• Greater San Diego Area

• Independent Clinical Research Consultant

  • 2013 - 2014

  Provide study management support via coordinating, monitoring, and quality assurance services. Provide study management support via coordinating, monitoring, and quality assurance services.



IQVIA

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

• QA Manager, Clinical Quality Assurance

  • 2010 - 2012

  Manager of a global study audit program over a 4 year period which consisted of 9 studies in 20 countries with 750 investigator sites and 4000 subjects. • Managed study audit program process and timelines. • Primary liaison with study sponsor counterpart. • Hosted FDA inspections and customer audits.• Provide QA consultation to project teams in the interpretation of regulations, guidelines, company policies, and procedures.• Assist project teams with the evaluation of audit findings and the formulation of corrective actions plans.• Oversaw the reporting, documentation, and closure of compliance issues.• Provided training to clinical staff on current industry regulations, guidelines and common audit findings. Show less

• Sr. Auditor, Clinical Quality Assurance

  • 2006 - 2010

  Provided QA oversight as the QA lead for all CNS studies in the US which required coordinating audit activities across multiple Quintiles offices and staff.• Primary liaison with study sponsor counterparts. • Provide QA consultation to project teams in the interpretation of regulations, guidelines, company policies, and procedures.• Hosted customer audits. • Assist project teams with the evaluation of audit findings and the formulation of corrective actions plans.• Oversaw the reporting, documentation, and closure of compliance issues.• Assisted in the training of new QA staff and mentored junior QA staff.• Plan, schedule, conduct, report and close various types of audits (e.g., investigator site, internal company process, and clinical study report) to assess for compliance with regulations, guidelines, and operating procedures. Show less

• Auditor, Clinical Quality Assurance

  • 2003 - 2006

  Provided QA oversight as the QA audit coordinator for assigned projects.• Provide QA consultation to project teams in the interpretation of regulations, guidelines, company policies, and procedures.• Assist project teams with the evaluation of audit findings and the formulation of corrective actions plans.• Presented at investigator meeting. • Plan, schedule, conduct, report and close various types of audits (e.g., investigator site, internal company process, and clinical study report) to assess for compliance with regulations, guidelines, and operating procedures. Show less

• Senior Clinical Research Associate/Lead CRA

  • 2001 - 2003

  Responsible for the oversight of multiple investigator sites of various phases of clinical trials. Verified study site compliance with applicable regulatory requirements, the study protocol, and good clinical practice.• Performed clinical study management activities in conjunction with project management (e.g., review and approval of monitoring and telephone contact reports and the coordination of monitoring activities across sites).• Established regular lines of communication with study sites to manage ongoing project expectations and issues.• Administered protocol and study related training to assigned sites.• Evaluated study site practices related to the proper conduct of the clinical trials and adherence to applicable regulations.• Presented study requirements at investigator site meetings.• Mentored junior clinical operations staff via co-monitoring visits. Show less

• Clinical Research Associate

  • 2000 - 2001

  Responsible for the on-site monitoring and oversight of multiple investigator sites of various phases of clinical trials. Verified study site compliance with applicable regulatory requirements, the study protocol, and good clinical practice.• Established regular lines of communication with study sites to manage ongoing project expectations and issues.• Administered protocol and study related training to assigned sites.• Evaluated study site practices related to the proper conduct of the clinical trials and adherence to applicable regulations. Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate

  • 1998 - 2000

  Responsible for the on-site monitoring and oversight of multiple investigator sites of various phases of clinical trials. Verified study site compliance with applicable regulatory requirements, the study protocol, and good clinical practice.• Established regular lines of communication with study sites to manage ongoing project expectations and issues.• Administered protocol and study related training to assigned sites.• Evaluated study site practices related to the proper conduct of the clinical trials and adherence to applicable regulations. Show less

• Clinical Studies Assistant

  • 1997 - 1998

  Provided administrative support for clinical projects and managed study trial master file. Managed the distribution and tracking of study documents, clinical trial supplies, case report forms and data queries. From this position obtained basic knowledge of applicable industry regulations and ICH guidelines.