Guillermo Sanz-Berney

Profile Summary

Sharp, efficiency-driven Health Informatics and Clinical Researcher with 12 years of related experience overseeing 25 Pharmaceutical- and Government-Sponsored Clinical Trials, Medical Research, Database Development, Budgets and Audits compliant with IRB, GCP, FDA and HIPAA regulations.  Meticulous with Electronic Data Capture or Collection, Biostatistics, Data Analysis, Web Semantics, and Scientific Writing.  Outgoing Team Trainer, Community Outreach Leader, and Patient Advocate.  Currently developing Patient-Centric Ontologies for shared decision-making in medicine.

Education

Professional Science Master in Medical / Health Informatics, SDSU, San Diego, CA, Spring 2013

Post-Doctorate Degree, University of California San Diego, San Diego, CA, 2005

M.D. with Honors, Universidad de Chile, Santiago, Chile, 1999

Achievements & Qualifications

„ Created and launched over 20 Core A programs for a nationally renowned Acute Kidney Injury facility:  Created and managed project budgets up to $80K, developed eCRFs, optimized staff workflows, forged strong manufacturer relationships, and launched basic research in novel renal function assays for UCSD.

„ Spearheaded digitization of data collection for all UCSD in-house and sponsored clinical trials:  Researched, recommended, and facilitated EDC software now used for campus-wide research data repositories and data management – resulting in $1.M to $2M in estimated annual cost savings.

„ Co-launched the cutting-edge medical knowledge resource Medpedia.com:  Established processes and formats, and created content to launch an online wiki that now boasts 20,000 unique visitors daily.

„ Developed over 20 applications and medical databases:  Created a detailed Web-based ontology for multi-factorial decision making by medical patients.  Adept with Java, Node.js, Microsoft SQL (MSSQL), MySQL, Protégé, OWL, XML, and Python.  Also savvy in Esri ArcGIS (GIS epidemiology or public health mapping), EpicCare, PCIS GOLD (practice management), and Microsoft Office.

Recent Service

Health Informatics Student & Leader                    San Diego State University, San Diego, CA                 8/2011 – present

As a National Science Foundation Statistical Scholarship recipient, completed a Master’s thesis in Web based ontology covering multi-factorial decision making by medical patients.

·     Developed the groundwork for an HL7 and SNOMED compliant ontology that facilitates improved patient decision-making for multiple, preference-sensitive treatment options such as late stage chronic kidney disease, arthritis, and depression.

·     Managed budgets, member payments, grants, and expenses as VP of Finance for SDSU’s 30-member Biomedical Technical Student Association from May 2012 to May 2013.

Medical / Science Editor & Reviewer                      Medpedia.com, San Francisco, CA                                6/2008 – present

Established editorial processes and created content for a wiki-style platform that presents information from health professionals in an easily accessible, easily understandable format.

·     Adapted over 200 pages from NIH and CDC to comply with visual and content guidelines, and rewrote complex medical terminology to make it easily understandable to average users.

·     Recommended and oversaw support for Spanish and other languages to expand market reach.

Clinical Research Program Mgr. / Data Mgr.  O'Brien Center, UCSD, San Diego, CA                      6/2008 – 10/2011

Managed a lab of 15 people, and directed nearly 20 projects and clinical trials for Nephrology / Acute Kidney Injury and CRRT research.  Trained staff, created budgets, created Core recharge mechanisms, procured all lab equipment, developed databases, initiated protocols, ensured data quality, and facilitated smooth communications between all parties.

·     Ensured regulatory compliance with IRB, FDA and HIPAA for all projects: managed and approved informed consents, research plans, protocols, brochures and other documents.

·     Initiated and planned budgets and resource allocation for all industry-sponsored projects.

·     Facilitated implementation of new clinical research managing software, VELOS.

·     Restructured the research group for more efficient workflow – creating SOPs and flowcharts to standardize practices and minimize training requirements.

·     Trained new staff in regulations, lab security, sample storage, and flow of information.

·     Educated all staff in all active trials and data collection or maintenance, including the move from PCIS to EPIC electronic medical records; and updated the website via SharePoint.

·     Coordinated all fellow and staff projects to maximize human resources; and liaised between study sponsors, research teams, and offsite PIs including offsite data managers.

·     Translated to Spanish over 100 documents that expanded the study to non-native English speakers, and interpreted for Spanish speaking subjects as needed.

·     Helped to grow the facility into a premiere reference research center by promoting it to the public and new sponsors; and forged strong relationships with novel AKI biomarker manufacturers.

Postdoctoral Scholar/Co-PI of Data Mgmt. UCSD / VA Health System, San Diego, CA                    5/2001 – 5/2008

Served as Study Coordinator and Co-PI for two NIH protocols: “Genetic Hypertension” and “Renal Dopaminergic Pharmacogenomics”: coordinated research subjects, lab activities, and data management.

·     Maintained updated knowledge of HIPAA, GCP, and other federal regulations for compliance.

·     Mentored over 300 undergraduate students in laboratory and human subject research, as well as physiopathology of the kidney and hypertension.

Postdoctoral Training Fellow                                 UCSD, San Diego, CA                                                                6/2001 – 6/2005

Gained extensive skills in clinical research of hypertension with focus on autonomic nervous system.  Joined an ongoing clinical research project sponsored by the NIH and pharmaceutical companies.

·     Migrated data collection from plain paper and Microsoft Excel to Access databases for later analysis.

·     Coordinated and processed regulatory documents using in-depth knowledge of IRB and HIPAA.

·     Liaised between the research group and the Spanish speaking community.

Attending Physician                                                     Consultorio Renca, Santiago, Chile                                5/1999 – 8/2000

Served as Director of TB Clinic, HIV Clinic and C.O.P.D. in a publicly funded clinic serving a poor population.  Revitalized the HIV, TB and STD Clinics by obtaining funding and establishing procedures to ensure availability of appointments and medications.

Attending Physician                                                     Instituto Nacional Geriátrico, Santiago, Chile          4/1999 – 8/2000

Cared for the elderly in a 120-bed hospital. Built strong relationships with all staff, and overcame short-staffing challenges by optimizing both patient flow and nurses’ inpatient bed assignments.

Highlighted Research

§  Sample Collection Study to Identify and Validate Urine Flow and Novel Biomarkers in Acute Kidney Injury

§  Sample Collection Study to Identify a Multi-Center Pilot Study to Assess the Safety and Efficacy of A Selective Cytopheretic Device In Patients with Acute Renal Failure

§  Randomized, Double-Blind, Interventional Trial to Assess the Impact of Two Epoetin alfa Dosing Strategies on Mortality and Cardiovascular Outcomes in ESA Hyporesponsive Patients with Chronic Kidney Disease

§  Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients with Metabolic Syndrome and Hypercholesterolemia at Moderately High and High Risk for Coronary Heart Disease

§  Multicenter Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

§  Multi-center, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of MK-0524B Versus Atorvastatin in Patients With Mixed Hyperlipidemia

§  Genetic Hypertension Study: Inheritance of Hypertension Phenotypes in families with History of Hypertension