Experience

HOPE Research Institute

• Research Services
• 1 - 100 Employee

• Director of Quality Management/ Regulatory Affairs

  • Nov 2013 - Present

  • Provide leadership and oversee day-to-day clinical research operations to ensure high performing teams and compliance with all applicable regulations and guidelines • Perform internal audits on source data noting deviations, errors, omissions, and/or inconsistencies • Ensure studies are being conducted according to FDA and ICH/GCP guidelines • Develop CAPA plans as needed for study coordinators • Assist in preparing for Sponsor and Regulatory Audits • Create and update source document worksheets for all protocols and protocol amendments • Effectively collaborate and communicate with Investigators, Sponsors, CROs, CRAs and Research participants • Assist in the training of new staff • Maintains a working knowledge of all protocols • Develop, implement, and maintain company standard operating procedures, processes, and best practices • Proficient in numerous Electronic Data Capture Systems (Rave, Oracle, Datalabs) • Maintain regulatory files for 40 plus studies across 4 sites • Complete initial IRB study submissions and continuing review reports • First line of contact for coordinators for questions regarding protocol executions



Clinical Research Advantage

• United States
• Research Services
• 1 - 100 Employee

• Regulatory Specialist

  • Sep 2013 - Nov 2013

  Maintained and updated regulatory documents for multiple sites. Maintained and updated regulatory documents for multiple sites.



Arizona Research Center

• United States
• Research Services
• 1 - 100 Employee

• Director of Quality Management

  • Aug 2007 - Nov 2010

  • Supervised 6 clinical research coordinators and 2 research assistants• Audited 100% of source documentation• Significantly increased work quality by reviewing each chart prior to randomization and after each visit• Provided training for new coordinators as well as ongoing GCP training to all coordinators• Designed and implemented standardized source for entire site• Created source documents for all new studies • Facilitated internal audits from pharmaceutical companies• Effectively communicated with sponsors and monitors regarding quality issues

• Clinical Research Coordinator

  • Jan 2001 - Aug 2007

  • Responsible for day-to-day coordination and management of Phase II-IV clinical drug trials• Successfully recruited study participants by utilizing fact-based enrollment• Experienced in numerous therapeutic areas including: Pain Management (post-op, chronic, and acute), Alzheimer's Disease, Primary Insomnia, Diabetic Neuropathy, Hypertension, Hypercholesterolemia, Erectile Dysfunction, and Attention Deficit Hyperactivity Disorder in children• Demonstrated effective management of clinical trials including preparation of source documentation, data collection, and severe adverse event reporting• Proven ability to manage multiple responsibilities without compromise to detail or quality• Managed 7 to 10 clinical trials at any one time• Demonstrated ability to translate technical information to patients• Recognized by physicians, clinical research associates and pharmaceutical companies for quality work and effective time-management skills• Accurately maintained inventory of investigational drug products including narcotics