Consultant, Biologics Consulting Group, Inc.
Boulder, CO.

• Clinical consultant working with drugs and biologics in Phases I through III of development;
  
• Medical writer with responsibility for analyzing and summarizing large, complex safety and efficacy data sets from clinical trials;
  
• Evaluate and provide input on Statistical Analysis Plans (SAPs) for individual clinical studies and pooled clinical data sets;
  
• Specialize in the preparation of Integrated Summary of Safety (ISS) and
• Summary of Clinical Safety (SCS) documents for Biologics License Applications (BLAs) and New Drug Applications (NDAs);
  
• Experienced in the preparation of clinical study protocols, clinical study reports, informed consent documents, IND Annual Reports, Investigator Brochures, IND
• Safety Reports
  
• Provide pharmacovigilance consulting services including serious adverse event processing plans, design and implementation of pharmacovigilance systems, and processing/reporting of SAEs
  
• Provide auditing services including GCP and Pharmacovigilance systems audits
  

Clinical Safety Associate II, OSI Pharmaceuticals, Boulder, CO.

• Worked with six products in Phases I through III of development
  
• Received, assessed, processed, and queried serious adverse event reports
  
• Prepared and submited expedited reports, analyses of similar events and investigator letters
  
• Assisted in data quality planning, CRF design, protocol review, informed consent preparation, and writing clinical study reports
  
• Worked closely with Regulatory and Clinical Departments, development partners, CROs and regional medical monitors to ensure timely and accurate reporting of clinical trial safety data
  
• Prepared periodic safety summaries, analyses, safety sections of IND Annual Reports and Investigator Brochures, and updated the development core safety information (DCSI) for these products
  
• Performed database reconciliation, coding review and query generation
  
• Authored departmental SOPs and guidelines
  

Clinical Safety Specialist/Consultant, Sirna Therapeutics/Ribozyme Pharmaceuticals, Boulder, CO.

• Performed all clinical safety data management activities for company
  
• Worked closely with Clinical, Biostatistics and Regulatory staff on protocol development, adverse event data collection planning, preparation of regulatory submissions, querying and data cleaning
  
• Responsible for preparation of SAE form and instructions, safety section of IND Annual Reports, Investigator Brochures, ad hoc safety summaries and materials for Investigator meetings
  
• Assisted in the identification of a safety signal and in notification of regulators and investigators

Professional Research Associate, University of Colorado School of Medicine, Denver, CO.

• Acted as a study coordinator for three ongoing clinical trials
  
• Assessed, treated and managed pulmonary hypertension patients, including performing study-related assessments
  
• Assisted in development of an investigator-sponsored protocol, designing the case report form, and creation of the study database
  
• Submitted protocols and informed consent documents to the local Institutional Review Board
  

Homeless Outreach Program, The People's Clinic, Boulder, CO.

• Co-created and managed a new homeless outreach nursing program
  
• Nurse case-managed medically fragile, homeless patients
  
• Created and maintained a program utilization database
  

Clinical Instructor, Jan. 1999 to Dec. 1999, Doctoral Resident and Research Fellow, Sept. 1997 to Jan. 1999, University of Colorado School of Nursing, Denver, CO.

• Completed an IRB-approved correlational study of 208 homeless women, regarding the relationship between their physical and mental health, substance abuse, family status and history of exposure to violence
  
• Trained doctoral residents and nursing students
  
• Assisted in creating a clinic and medical case management program

Family Nurse Practitioner Program, 1999 to 2001, Nursing Doctorate Program, 1995 to 1999, University of Colorado Health Sciences Center, Denver, CO

• Full-time graduate nursing student, completing over 3,000 hours of direct patient care and 1,000 hours of research during the period
  
• National Health Service Corps Fellow, 1996