PSI CRO AG
Industry: Company
DescriptionFounded: 1995 Subsidiary: Grifon ZAO
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PSI CRO AG Employees
PSI CRO AG October 2001 - March 2015
PRA International October 1997 - October 2001
Covance November 1992 - October 1997
Lederle March 1987 - 1992
Skills
CRO, CTMS, Clinical Trials, Clinical Development, GCP, Oncology, EDC, Clinical Research, Clinical Monitoring, Pharmaceutical Industry, Therapeutic Areas, ICH-GCP, Cardiology, Biotechnology, Medical Devices, Pharmacovigilance, Neurology, Infectious Diseases, Hematology, Nephrology, New Business Development, Commercialization, Drug Development, Trial Management, Diabetes, Medical Writing, Regulatory Submissions, Protocol, Clinical Data Management, Immunology, Medical Affairs, Regulatory Affairs, Inform, Lifesciences, Vaccines, Endocrinology, Sop, Cancer, Asthma, Biopharmaceuticals, FDA, Psychiatry, Regulatory Requirements, Clinical Operations, Phase I, Pharmacology, Pharmaceutical Sales
Education
University of Wisconsin-Madison 1983 — 1986
Pre-Med
College of Marin 1978 — 1982
ADN, Nursing
Siena Heights University 1970 — 1974
BSW, Social Work and Psychology
St. Thomas High School
inVentiv Health Clinical July 2013 - Present
inVentiv Health Clinical May 2012 - July 2013
PSI CRO AG February 2012 - May 2012
PSI CRO AG July 2010 - February 2012
Ascenta Therapeutics, Inc. January 2008 - June 2010
Skills
Clinical, Clinical Trials, CRO, EDC, Clinical Monitoring, Clinical Research, ICH-GCP, GCP, CTMS, Clinical Development, Sop, Regulatory Submissions, Protocol, FDA, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Site Monitoring, SOP
Education
University of Delaware 2006 — 2010
BA, Biologcial Sciences with a minor in Business Administration
Delaware County Christian School 2002 — 2006
Technische Universität München March 2014 - August 2014
Universität für Bodenkultur October 2013 - March 2014
Technische Universität München April 2013 - September 2013
Universitá di Bologna September 2012 - March 2013
PSI CRO AG April 2012 - August 2012
CREG 2009 - 2011
Skills
Biotechnology, Horticulture, Plant Genetics, Molecular Biology, Molecular Cloning, Laboratory Skills, Bioinformatics, PCR, Microsoft Office, English, Spanish, Italian
Education
Università di Bologna 2012 — 2014
Master's Degree, Horticultural Science, 110 cum laude
Universidad Nacional de Quilmes 2006 — 2011
Licenciada, Biotecnología, 8.75
PSI CRO AG January 2008 - Present
Skills
CTMS, CRO, GCP, Clinical Monitoring, ICH-GCP, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Infectious Diseases, Clinical Operations, IND, Diabetes, FDA, Protocol
Education
Rajiv Gandhi University of Health Sciences 1996 — 2002
Bachelor of Medicine, Bachelor of Surgery (MBBS), Medicine
Pfizer March 2014 - Present
ExecuPharm November 2013 - March 2014
PSI CRO AG January 2013 - November 2013
Execupharm August 2007 - November 2012
GSK August 2004 - August 2007
Skills
CRO, CTMS
Education
University of North Carolina at Chapel Hill 1994 — 1998
Bachelor of Science in Nursing
Spectrum Pharmaceuticals August 2014 - Present
PSI CRO AG August 2013 - July 2014
EMD Serono, Inc. 2008 - 2013
Schering-Plough Research Institute 1998 - 2008
Skills
CTMS, Clinical Trials, GCP, Clinical Development, CRO, Clinical Monitoring, Oncology, EDC, Biotechnology, Clinical Data Management, Regulatory Affairs, ICH-GCP, Clinical Research, Therapeutic Areas, Neurology
Education
University of Kentucky 1983 — 1987
University of Kentucky
PSI CRO AG December 2012 - Present
Human Genome Sciences January 2011 - November 2012
Human Genome Sciences January 2007 - January 2011
Human Genome Sciences January 2006 - January 2007
Skills
Biotechnology, Oncology, Sop, Clinical Development, Immunology, Clinical Trials, GCP, EDC, Infectious Diseases, CRO, CTMS, Clinical Monitoring, Drug Development, GMP, Clinical Operations, Protocol, Clinical Data Management
Education
Montgomery College 2002 — 2007
Associate's degree, General Studies
The George Washington University
Bachelor’s degree, Clinical Research Administration
PSI CRO AG December 2008 - Present
PRA International September 2006 - December 2008
Hurley Consulting Associates, Ltd. January 2005 - September 2006
Tercica, Inc March 2003 - October 2004
Nuvelo 2002 - 2004
Acologix, Inc. 2000 - 2002
Sensus Drug Development Corp. 1995 - 2000
Titan Pharmaceuticals 1994 - 1995
Gillette, Inc. 1993 - 1993
Genentech 1990 - 1992
Skills
Clinical Trials, Biotechnology, Clinical Development, Oncology, Pharmaceuticals, Lifesciences, Pharmaceutical Industry, GCP, CRO, Infectious Diseases, Regulatory Submissions, Regulatory Affairs, CTMS, Clinical Research, Clinical Monitoring, Sop, Business Development, Therapeutic Areas, Drug Development, Drug Discovery, Clinical Data Management, ICH-GCP, EDC, Life Sciences
Education
University of California, Los Angeles 1983 — 1986
BS, Psychobiology
University of California, Santa Cruz 1981 — 1983
Pre-med
Campolindo 1979 — 1981
Tutoring September 2004 - Present
Globus International December 2009 - April 2015
Saint-Petersburg State University of Culture and Arts September 2013 - May 2014
Film Company RosMedia Production (film 'Grigory R.') May 2013 - February 2014
OAO Ilim Group (Wood industry) October 2008 - October 2012
PSI CRO AG September 2005 - October 2008
Public School №636 September 2004 - May 2005
Intourist August 2004 - October 2004
Education
Herzen State Pedagogical University of Russia 2000 — 2005
Bachelor's degree, Teaching English or French as a Second or Foreign Language
ICON Clinical Research April 2015 - Present
ICON Clinical Research February 2013 - March 2015
PSI CRO AG March 2012 - January 2013
PSI CRO AG February 2011 - March 2012
Pfizer Pharmaceuticals August 2010 - January 2011
Reel Wire Supplies, LLC March 2009 - August 2010
ICON Clinical Research August 2006 - March 2009
ICON Clinical Research March 2004 - July 2006
Commonwealth Bank October 1985 - February 2003
Skills
CRO, GCP, CTMS, ICH-GCP, Clinical Monitoring, EDC, Lifesciences, Clinical Trials, Regulatory Affairs, Oncology, Cardiology, Medical Writing, Pharmaceutical Industry, Clinical Research, Diabetes, Pharmacovigilance, Infectious Diseases
Education
Montgomery County Community College
Business English and Algebra
Lansdale School of Business
Business English and Word Processing
American Institute of Banking
Careers In Research, Inc. March 2010 - Present
The Electronic Source, LLC 2013 - 2013
PSI CRO AG 2011 - 2012
PSI CRO AG 2011 - 2012
i3 Research 2009 - 2010
GlaxoSmithKline 2006 - 2007
Aerotek 2004 - 2005
inVentiv Clinical Solutions 2004 - 2005
MedExec International/Novartis 2003 - 2004
Skills
Clinical Monitoring, Clinical Trials, CTMS, CRO, GCP, Regulatory Affairs, Clinical Development, Trial Management, EDC, ICH-GCP, Clinical Research, Oncology, Clinical Data Management, Patient Recruitment, Therapeutic Areas, Sop, Infectious Diseases, Drug Development, Regulatory Submissions, Oracle Clinical, Pharmaceutical Industry, Protocol, Clinical Operations, Clinical Research..., Pharmacovigilance, IRB, Inform, Vaccines, CRF design, Clinical Study Design, SOP
Education
University of California, Davis 1989 — 1993
BS, Psychology/Premed
PRA Health Sciences March 2015 - Present
Covance March 2014 - March 2015
Covance July 2011 - March 2014
Quintiles December 2010 - July 2011
PSI CRO AG October 2008 - December 2010
Merck June 2008 - August 2008
Skills
GCP, Clinical Trials, Regulatory Submissions, Protocol, Sop, Clinical Research, Therapeutic Areas, Software Documentation, Training, Budgets, Clinical Monitoring, CRO, Clinical Development, ICH-GCP, CTMS, Oncology, EDC, Pharmaceutical Industry, Pharmacovigilance, Clinical Data Management
Education
Sofia University St. Kliment Ohridski 2001 — 2007
PhD, Molecular Biology
Second English Language School "Thomas Jefferson" - Sofia, Bulgaria
PSI CRO AG August 2011 - Present
National Institute of Pharmacy October 1998 - May 2011
Izinta,Trade Subsidiary of the Isotope Institute September 1990 - October 1998
Skills
Clinical Trials, Regulatory Submissions, Regulatory Affairs, Regulatory Requirements, ICH-GCP, GCP, Pharmacovigilance, CTMS, CRO, Clinical Development, Pharmaceutics, Therapeutic Areas, Clinical Monitoring, Perfect Russian, EMA, Expert at EMA, Regulatory Affairs in..., Pharmaceutical Industry
Education
Semmelweis Egyetem 1984 — 1990
MS, pharmacy
College for Foreign Trade 1992 — 1994
MS, economy
PSI CRO AG June 2013 - Present
IBM July 2012 - June 2013
C3i Europe June 2010 - June 2012
Skills
Quality Assurance, Service Delivery, Sla, Troubleshooting, Call Center, ITIL, IT Service Management, Customer Satisfaction, Incident Management, Team Leadership, Process Improvement, Technical Support, Citrix, Teamwork
Education
Universiteit Antwerpen 2010 — 2012
Master's degree, Business, Management, Marketing, and Related Support Services
Katholieke Hogeschool Leuven 2006 — 2009
Bachelor's degree, Business, Management, Marketing, and Related Support Services
Katholieke Universiteit Leuven 2004 — 2006
Lycée Francais "Antoine de Siant Exupery" 1999 — 2004
Worldwide Clinical Trials July 2015 - Present
Worldwide Clinical Trials, Inc. July 2010 - June 2015
PSI CRO AG June 2006 - June 2010
PSI CRO AG November 2009 - January 2010
Vreden's Russian Research Institute of Traumatology and Orthopedics August 2001 - November 2007
Skills
Oncology, Neurology, Breast Cancer, Pulmonology, Melanoma, CTMS, Clinical Trials, CRO, Microsurgery, Clinical Monitoring, GCP, EDC, ICH-GCP, Clinical Development, Clinical Research, Biotechnology, Cancer, Immunology, Pharmaceutical Industry
Education
Saint Petersburg Medical Academy of Post-Graduate Education 1998 — 2001
MD, Traumatology and Orthopedics, post-grad
Saint Petersburg State Pediatric Medical Academy 1992 — 1998
MD, Medicine
PSI CRO AG December 2007 - Present
ICON Medical Imaging September 2006 - October 2007
Bovis Lend Lease, Inc January 1999 - January 2002
Skills
Sop, Clinical Trials, FDA, Pharmaceutical Industry, GCP, Validation, Software Documentation, Regulatory Affairs, CTMS, Clinical Research, CRO, Clinical Development, Oncology, Clinical Operations, ICH-GCP, Regulatory Submissions, 21 CFR Part 11, Clinical Data Management, Drug Development, Pharmacovigilance, Data Management, EDC, Therapeutic Areas, Protocol, SOP
Education
Montclair State University 1989 — 1993
BFA
Kaplan University
Legal Studies
Pennsylvania State Notary
PSI CRO AG November 2011 - Present
PSI CRO AG January 2011 - Present
PSI Pharma Support Intl April 2009 - December 2010
PSI Pharma Support Intl January 2008 - March 2009
Acurian October 2003 - January 2008
eResearch Technology May 2002 - October 2003
Quest Diagnostics June 2001 - May 2002
Skills
CRO, Clinical Development, Clinical Trials, CTMS, GCP, Clinical Research, Feasibility Studies, Patient Recruitment, Clinical Monitoring, ICH-GCP, EDC, Regulatory Affairs, Biotechnology, Therapeutic Areas, Pharmaceutical Industry, Drug Development, Oncology, Sop, Medical Affairs, Cancer
Education
Cabrini College 1987 — 1992
BS, Biology
PSI CRO AG September 2015 - Present
Premier Research October 2013 - January 2015
Covance November 2011 - October 2013
Telerx - Subsidiary of Merck Pharmaceutical Company March 2008 - April 2011
Save The Date Event Consultants, LLC May 2007 - June 2007
Skills
Clinical Trials, Customer Service, FDA, Training, Lotus Notes, GCP, Outlook, Time Management, FMLA, Microsoft Office, PeopleSoft, Databases, Clinical Research, Employee Training, SharePoint, ICH-GCP, CRO, eTMF, iTRACK system, SOP's, Internal Audit, External Audit, Microsoft Excel, Regulatory Compliance, Clinical Operations, Biometrics, Medical Affairs, Event Planning, Business Planning
Education
Pennsylvania State University-Penn State Abington 2003 — 2007
Bachelor of Arts (BA), Corporate Communication
PSI CRO AG October 2012 - January 2015
Zog Inc May 2012 - October 2012
MindShift Technologies Inc July 2010 - December 2011
The eSource Group, Inc August 2004 - June 2010
Merck and Company, Inc May 2004 - August 2004
Cerexagri, Inc April 2004 - May 2004
Viropharma, Inc January 2002 - March 2004
Poulenc-Rorer January 1997 - January 2002
Skills
Windows Server, Troubleshooting, VMware, ITIL, Technical Support, Servers, Microsoft Technologies, Networking, Information Technology, Operating Systems, Blackberry Enterprise..., Disaster Recovery, Security, IT Management, Active Directory, Microsoft Exchange, Vendor Management, VMware ESX, Cloud Computing, Virtualization, Data Center, IT Hardware Support, System Deployment, Avaya IP Telephony, Integration, Management, CRO, Pharmaceutical Industry
Education
Immaculata University 2010 — 2014
Bachelor of Arts (B.A.), Information Technology Business Management Program, GPA 3.77
Pennco Technical 1980 — 1983
Associate Degree, Specialized Electronic Engineering, 3.8
PSI CRO AG January 2014 - Present
Genzyme (a Sanofi company) through ReSearch Pharmaceutical Services April 2010 - December 2013
Sirion Therapeutics 2005 - February 2010
Rx Development Resources, Tampa, FL 2005 - February 2010
Self Employed 2003 - 2009
Psychological Assessment Resources, Inc. 2003 - 2005
Synergy Medical Communications 2001 - 2003
Skills
Leadership, Medical Writing, Regulatory Documentation, Clinical Study Design, Publications, Biotechnology, Ophthalmology, Rare Diseases, Infectious Diseases, Medical Communications, Pharmaceutical Industry, Editing, Scientific..., NDA, IND, Protocol Design, Cardiology, Multiple Sclerosis, Clinical Trials, CME, Medical Affairs, Clinical Development, Management, Regulatory Submissions, Oncology, Regulatory Affairs, CRO, GCP, Life Sciences, Drug Development, Clinical Research
Education
American Medical Writers Association
Core Certificates in Pharmaceutical Education and Writing/Editing
Louisiana State University
Southern Methodist University
PSI CRO AG February 2014 - Present
PSI CRO AG September 2011 - January 2014
OSMOS Clinical Research, Inc. October 2008 - August 2011
Skills
Research, Employee Training, Project Management, New Business Development, Life Sciences, Data Analysis, Data Entry, Payments Coordination
Education
City College of San Francisco 2005 — 2006
English as a second language, Social Communications
Елецкий Государственный Университет им. И.А. Бунина / Yelets State University of Bunin 1999 — 2004
B.S. Economics, Accounting, and Auditing, Economics, Accounting, and Auditing
PSI CRO AG September 2012 - Present
PSI CRO AG June 2010 - August 2012
PSI CRO AG November 2009 - May 2010
Skills
CRO, ICH-GCP, Microsoft Office 2007, GCP, Clinical Monitoring, Clinical Trials, Clinical Operations, GCP certificate, Proofreading, Regulatory Submissions, EDC, Clinical Data Management, Ballroom Dance, Clinical Development, Driver's licence, FDA inspection, PA/CTA..., CTMS, Pharmaceutical Industry, Clinical Research, Therapeutic Areas, Regulatory Affairs
Education
Universidad San Pablo-CEU 2008 — 2009
Budapest Business School (Budapesti Gazdasági Főiskola) 2005 — 2009
economist, economic diplomacy
Plexxus July 2013 - Present
AlexSoft September 2011 - July 2013
PSI CRO AG October 2007 - August 2011
Kurgan State University September 2003 - September 2007
Skills
Project Management, Software Documentation, Training, Management, Teamwork, GCP, CTMS, EDC, CRO, Clinical Trials, Testing, English, Marketing Communications, Sop, Clinical Development, HTML, Oncology, Microsoft Office, Microsoft SQL Server, Regulatory Affairs
Education
Kurgan State University
B.A. in Linguistics
Kurgan State University 2001 — 2002
Diploma, Computer Programming
Seneca College of Applied Arts and Technology
Certificate, QuickBooks
University of Toronto
PSI CRO AG May 2014 - Present
CFS Clinical December 2011 - May 2014
Main Line Media News May 2011 - December 2011
Aetna September 2004 - May 2011
Aetna September 2002 - September 2004
Aetna September 1999 - September 2002
Aetna September 1998 - September 1999
Aetna September 1997 - September 1998
Aetna May 1996 - September 1997
Verizon Com January 1993 - January 1996
Skills
Clinical Trials, Accounts Payable, Process Improvement, Finance, Customer Service, Microsoft Excel, SAP, Invoicing, Accounts Receivable, Health Insurance, Vendor Management, Communication, Leadership, Accounting, Management, Policy, Clinical Research, Internal Audit, Team Building, Testing, Medicare, User Acceptance Testing, Training, Microsoft Office, Microsoft Word, Outlook, Healthcare, PowerPoint, Project Management, Budgets, Pharmaceutical Industry
Education
Temple University 1987 — 1991
Bachelors, Business Administration/Marketing
Temple University
Bachelor's degree, Business Administration and Management, General
Medsurant Holdings, LLC May 2015 - Present
PSI CRO AG January 2015 - May 2015
Devon International Group January 2011 - January 2015
Allied Barton Security Services November 2010 - January 2011
McBee Associates Inc May 2010 - November 2010
BravoSolution September 2008 - May 2010
Skills
Microsoft Exchange, Windows Server, Active Directory, VPN, VMware, Microsoft Office, Troubleshooting, Networking, Citrix, Software Installation, Help Desk Support, Windows 7, Disaster Recovery, Linux, Windows XP, Information Technology..., SaaS, XML, Remote Troubleshooting
Education
Montgomery County Community College 2006 — 2009
Associates in Applied Science Degree (AAS) in Computer Networking, Computer Systems Networking and Telecommunications
Montgomery County Community College
Associates in Applied Sciences in Computer Networking
PSI CRO AG October 2014 - Present
PSI CRO AG February 2012 - September 2014
AstraZeneca April 2010 - December 2011
AstraZeneca January 2009 - August 2009
AstraZeneca 2006 - 2009
Skills
Clinical Trials, Pharmaceutical Industry, Oncology, Clinical Research, CTMS, ICH-GCP, CRO, Sop, GCP, Pharmacovigilance, Regulatory Submissions, Pharmaceutical Sales, Protocol, Diabetes, Therapeutic Areas
Education
Budapest Tech 2005 — 2010
Bachelor of Science (BSc), Printing and Media Engineering, Light Industry
Metropolia Ammattikorkeakoulu 2009 — 2009
Bachelor of Science (BSc), Media Engineering
PSI CRO AG June 2011 - Present
PSI CRO AG April 2008 - May 2011
Gamesa November 2006 - April 2008
Royal China & Porcelain February 2005 - November 2006
Kulicke and Soffa July 2003 - January 2005
Skills
General Ledger, Financial Reporting, Budget Development, Internal Controls, Intercompany, Payroll Administration, Benefits Administration, Fixed Assets, Insurance, Process Improvement, 401k, Project Finance, CRO, Start-ups, Payroll, US GAAP, Budgets, ADP HRB, Grants Management, SAP Implementation, Lifesciences, Finance, Accounts Receivable, CTMS, Financial Statements
Education
Holy Family University 2003 — 2004
Accounting
Community College of Philadelphia 1998 — 2002
Accounting and Finance
Belarusian State University 1993 — 1996
Finance
PSI CRO AG December 2014 - Present
ICON Clinical Research September 2010 - December 2014
Eisai Global Clinical Development September 2008 - December 2009
Daiichi Sankyo Development April 2007 - August 2008
Daiichi Medical Research January 2005 - March 2007
Daiichi Pharmaceutical Corporation October 2001 - December 2004
Purdue Pharma 2001 - 2001
Omnicare Clinical Research 1999 - 2001
ClinTrials/Charles River Labs 1998 - 1999
Schering-Plough Research Institute September 1996 - April 1998
Skills
Pharmaceuticals, Clinical Trials, Clinical Development, Infectious Diseases, Diabetes, R&D, Internal Medicine, Cardiology, Clinical Research, Medical Affairs, Medicine
Education
Drexel University College of Medicine 1984 — 1987
New Britain General Hospital 1982 — 1984
St. George's U. School of Medicine 1978 — 1982
Doctor of Medicine (M.D.), Medicine
Medical University of South Carolina College of Medicine 1972 — 1975
M.S., Microbiology
Columbia University in the City of New York 1969 — 1970
Science
Bucknell University 1965 — 1969
B.S., Biology
PSI CRO AG July 2011 - Present
PSI CRO AG October 2007 - July 2011
PSI CRO AG December 2003 - October 2007
Skills
CTMS, Clinical Monitoring, CRO, GCP, Clinical Trials, ICH-GCP, EDC, Regulatory Submissions, Therapeutic Areas, Clinical Development, Oncology, Pharmacovigilance, Sop, Infectious Diseases, Project Delivery, Clinical Data Management, Clinical Research, Drug Development, Neurology, Protocol, Regulatory Affairs, Project Management, Clinical Operations, Phase I, Patient Recruitment, Pharmaceutical Industry, Trial Management, SOP
Education
National Medical University 'O.O. Bogomolec', Kyiv 1988 — 1994
MD
PSI CRO AG May 2014 - Present
Safeguard Business Systems June 2013 - May 2014
Safeguard Business Systems January 2012 - June 2013
Safeguard Business Systems November 2009 - January 2012
MDS Pharma Services July 2009 - November 2009
MDS Pharma Services August 2008 - June 2009
Teva Neuroscience June 2006 - August 2008
PPD October 2004 - May 2006
Unisys June 2000 - October 2004
Skills
Budgets, Project Planning, Process Improvement, Financial Analysis, Microsoft Excel, Strategic Planning, Management, Forecasting, Financial Reporting, Account Management, Customer Service, Team Building, Cross-functional Team..., Analysis, Microsoft Office, Team Leadership, Six Sigma, Outlook, Accounting
Education
Saint Joseph's University 2001 — 2007
MBA, Finance
Ursinus College 1997 — 2000
BA, Economics and Business Administration
CEB
Risdahl Clinical Research Incorporated April 1999 - Present
InClin, Inc December 2012 - Present
CSL Behring November 2010 - Present
PSI CRO AG October 2011 - October 2014
Oncolytics Biotech Inc. November 2011 - February 2014
Morphotek, Inc. August 2011 - January 2013
Paragon Biomedical (Now Clinipace Worldwide) 1999 - 2010
Quintiles August 2009 - December 2009
Sanofi 2006 - 2009
Scimega Research November 2002 - December 2005
Skills
Clinical Site Management, EDC, CTMS, Oncology, Clinical Research, Diabetes, Rheumatology, Asthma, COPD, ICH-GCP, Clinical Monitoring, GCP, CRO, Clinical Development, Clinical Trials, Therapeutic Areas, Clinical Data Management, Regulatory Affairs, Pharmacovigilance, Sop, Cardiology, Clinical Operations, Nonprofits, Team Leadership, Oracle Clinical, Patient Recruitment, Inform, Regulatory Submissions, Pharmaceutical Industry, Infectious Diseases, Protocol, FDA, Biotechnology, Vaccines
Education
Barnett International 2013 — 2015
Certification
SoCRA - Society of Clinical Research Professionals 2011 — 2013
CCRP - Certified Clinical Research Professional
DIA - Drug Information Association 1999 — 2010
ACRP - Association of Clinical Research Professionals 2000 — 2009
CCRA (Certified Clinical Research Associate)
University of Calgary 1993 — 1994
Canadian Hospital Association (now Canadian Healthcare Association) 1989 — 1991
Departmental Management
Southern Alberta Institute of Technology 1985 — 1987
Registered Respiratory Therapist (RRT)
Accelovance, Inc. May 2015 - Present
PSI CRO AG May 2013 - August 2014
Light Ahead Consulting 2001 - 2014
Bristol-Myers Squibb May 2009 - November 2012
KaloBios February 2005 - December 2006
PDL June 1998 - December 2000
Roche Pharmaceuticals November 1990 - June 1998
Skills
Clinical Trials, Pharmaceutical Industry, Biotechnology, Clinical Development, Oncology, Transplant/Immunology, Immunology, Clinical Research, FDA, Monoclonal Antibodies, Drug Development, Medical Affairs, Infectious Diseases, CRO, GCP, Drug Discovery
Education
Clark University
Bachelor's degree, Chemistry
Columbia University College of Physicians and Surgeons
MD, Medicine
Columbia University College of Physicians and Surgeons
Doctor of Medicine (MD)
Taylor Allderdice High School
Medical Components, Inc. February 2015 - Present
Merck Sharp & Dohme Corp. (Contract) January 2012 - June 2014
Pfizer Consumer Health (Contract) August 2011 - January 2012
PSI CRO AG September 2010 - April 2011
AstraZeneca Pharmaceuticals March 2002 - September 2010
Skills
Pharmaceutical Industry, Clinical Trials, CRO, Clinical Research, Regulatory Affairs, Regulatory Submissions, Documentum, GCP, CTMS, Clinical Development, Biotechnology, ICH-GCP, Sop, FDA, Microsoft Office, Life Sciences, GMP, Drug Development, 21 CFR Part 11
Education
Drexel University
PSI CRO AG June 2014 - Present
PSI-CRO AG April 2013 - May 2014
PSI CRO AG August 2011 - March 2013
Textron Financial February 2006 - October 2008
Compass Foods November 2004 - February 2006
American Home Products/Ayerst Laboratories 1986 - 1987
Sterling Drug/Winthrop Laboratories 1975 - 1986
Skills
Healthcare Information..., Software Documentation, Management, Customer Service, Clinical Trials, Healthcare, Clinical Research, Public Speaking, Oncology, Start-ups, EHR, CRO, CTMS, Training, Pharmaceutical Industry, Project Management, Sales, GCP, Clinical Development, ICH-GCP
Education
Gwynedd Mercy University 2009 — 2011
AS, Majoring in Health Information Technology
PSI CRO AG September 2009 - Present
Optimum Látásjavító Lézerközpont September 2005 - August 2009
Skills
Clinical Trials, CRO, GCP, Regulatory Submissions, ICH-GCP, Regulatory Affairs, Clinical Data Management, Clinical Pharmacology, Regulatory Documentation, Medical Writing, Clinical Operations, Regulatory Requirements, Clinical Research, IND, Phase I, Medical Devices, IRB, Drug Safety, Endocrinology, Trial Management, Pharmaceutical Industry, Drug Development, eCTD, Infectious Diseases, CTMS, FDA, Clinical Monitoring, Protocol, GLP, Pharmaceutics, Biologics, Clinical Study Design, Hematology
Education
Semmelweis Egyetem 2001 — 2005
Bachelor, Health Sciences
INC Research April 2015 - Present
Salix Pharmaceuticals May 2014 - April 2015
PRA International January 2013 - April 2014
PSI CRO AG June 2012 - January 2013
i3 Research March 2011 - June 2012
i3 Research December 2007 - March 2011
MDS Pharma Services February 2006 - November 2007
Advanced Clinical Research Institute June 2002 - February 2006
Medical Research Associates November 2001 - June 2002
Los Baños Doctors Hospital November 1999 - April 2000
Skills
CTMS, Clinical Monitoring, GCP, CRO, ICH-GCP, EDC, Clinical Trials, Clinical Development, Therapeutic Areas, Clinical Data Management, Oncology, Clinical Operations, Infectious Diseases, Regulatory Submissions, Hematology, Dermatology, Neuroscience
Education
Excelsior College 2002 — 2003
Associate of Science (A.S.), Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing
University of Santo Tomas 1994 — 1998
Doctor of Medicine, Medicine
University of Santo Tomas 1990 — 1994
Bachelor of Science, Medical Technology
PSI CRO AG January 2014 - Present
MethylGene Inc. (a division of Mirati Therapeutics Inc.) January 2011 - December 2013
MethylGene Inc. (a division of Mirati Therapeutics Inc.) April 2005 - December 2010
McGill University May 1995 - March 2005
Saint-Luc Hospital May 1985 - April 2000
McGill University September 1985 - May 1995
Skills
Supervisory Skills, In Vivo, Oncology, Research, Infectious Diseases, Immunology, Molecular Biology, Clinical Research, Clinical Development, GLP, Pharmacology, Drug Development, Clinical Monitoring, Clinical Trials, Cancer, Pharmacokinetics, Laboratory, Drug Discovery, Immunohistochemistry, CRO, Protocol, Biotechnology, Toxicology, Lifesciences, In Vitro, Biochemistry, Vaccines, Microsoft Office, eCRF, Clinical Research..., Life Sciences
Education
Charles Sturt University 1998 — 2002
Bachelor's Degree
Collège de Rosemont 1982 — 1985
DEC
PSI CRO AG May 2014 - Present
Fresenius Medical Care January 2011 - April 2014
PharmaNet Development Group, Inc. February 2007 - January 2011
PharmaNet Development Group, Inc. September 2005 - February 2007
Eximias Pharmaceuticals August 2004 - August 2005
Quality Data Services September 2003 - September 2004
Omnicare Clinical Research July 2001 - September 2003
Omnicare Clinical Research 2001 - 2003
Omnicare Clinical Research 2001 - 2003
Kennedy Health System September 1995 - April 1999
Skills
Clinical Data Management, CRO, Clinical Monitoring, GCP, Oncology, EDC, Infectious Diseases, ICH-GCP, Inform, 21 CFR Part 11, Nephrology, Clinical Development, Clinical Research, CTMS, Clinical Trials, Dialysis, Therapeutic Areas, Protocol, Clinical Operations
Education
Cittone Institute
Saint Joseph's University
MHA, Healthcare Administration
Temple University
BSN, Nursing
PSI CRO AG March 2014 - Present
PSI CRO AG January 2012 - Present
PSI CRO AG August 2007 - January 2012
PSI CRO AG October 2004 - August 2007
St. Nicholas Hospital 2002 - 2004
Saint Petersburg State Pediatric Medical Academy 2002 - 2004
Ott Research Institute of Obstetrics and Gynecology 1999 - 2002
Ott Research Institute of Obstetrics and Gynecology 1995 - 1999
Skills
Microsoft Office, Research, Pharmacovigilance, Infectious Diseases, Therapeutic Areas, Clinical Trials, Protocol, Medical Affairs, Clinical Operations, Cardiology, Medicine, Clinical Study Design, Clinical Research, Clinical Development, Oncology, CRO
Education
Albany Medical College 1996 — 1996
international fellowship
Ott Research Institute of Obstetrics and Gynecology 1993 — 1995
Doctor of Philosophy (PhD), residency in neonatology
Saint Petersburg State Pediatric Medical Academy 1985 — 1993
Doctor of Medicine (MD), pediatrics
PSI CRO AG November 2013 - Present
Theradex December 2007 - November 2013
eResearch Technology 2004 - 2007
Skills
EDC, Clinical Monitoring, CRO, CTMS, GCP, Drug Development, Therapeutic Areas, ICH-GCP, Clinical Data Management, Clinical Trials, Oncology, Clinical Development, 21 CFR Part 11, Protocol, Sop
Education
Rutgers University-New Brunswick 1998 — 2002
BA, Biology
PSI CRO AG 2012 - Present
Batson Consulting 2011 - 2012
Rho, Inc. July 2009 - July 2011
Talecris Biotherapeutics, Inc. February 2008 - July 2009
MediQuest Therapeutics, Inc. 2006 - 2007
Batson Consulting 1998 - 2006
Sonus Pharmaceuticals 1996 - 1998
Abbott Laboratories 1990 - 1996
American Medical Association 1984 - 1990
Education
The University of Texas Southwestern Medical School 1980 — 1989
PhD, Medical Computer Science
Medical College of Pennsylvania 1975 — 1979
MD
Dartmouth College 1971 — 1975
AB, Mathematics and Biology
PSI CRO AG May 2014 - Present
PSI CRO AG September 2013 - May 2014
PSI CRO AG October 2012 - September 2013
AstraZeneca January 2012 - July 2012
American College of Radiology Imaging Network (ACRIN) November 2008 - December 2011
American College of Radiology April 2007 - November 2008
Skills
Clinical Trials..., Outlook, Website Maintenance, Go to Webinar/Meeting, Survey Monkey, Oracle, Citrix, Microsoft Office, IMPACT, ISIS, E-Room, Clinical Partners Portal, Global Electronic..., Clinical Research, Clinical Trials, SurveyMonkey, Oncology, GCP, Leadership, Protocol, Pharmaceutical Industry, Quality Assurance, CTMS, Nonprofits, Webmaster Services, CRO
Education
University of Phoenix 2008 — 2010
MHA, Health Administration
Temple University 1996 — 2002
BS, Management/Marketing
PSI CRO AG June 2014 - Present
Synta Pharmaceuticals November 2013 - April 2014
Ziopharm Oncology July 2013 - November 2013
AVEO Oncology January 2012 - June 2013
AVEO Oncology December 2007 - December 2011
ARIAD Pharmaceuticals, Inc. February 2006 - November 2007
Agenus (formerly Antigenics) April 2003 - January 2006
Muro Pharmaceuticals January 2002 - February 2003
PAREXEL October 1999 - December 2001
Skills
Oncology, Clinical Trials, GCP, Clinical Development, CRO, Clinical Operations, Clinical Research..., Drug Development, EDC, CTMS
Education
University of Massachusetts Lowell 1994 — 1999
MS, Biological Sciences
Bridgewater State University 1990 — 1994
BS, Biology
PSI CRO AG 2015 - Present
PSI CRO AG 2012 - 2015
PSI CRO AG 2010 - 2012
Pharmacopola 2005 - 2011
PSI CRO AG 2009 - 2010
PSI CRO AG 2007 - 2009
Education
ISM Vadybos ir ekonomikos universitetas 2009 — 2010
Master's degree, Management
Kauno Medicinos Universitetas 2002 — 2007
Master's degree, Pharmacy
Bayer HealthCare January 2015 - Present
PSI CRO AG March 2013 - December 2014
Bristol-Myers Squibb June 2011 - February 2013
Bristol-Myers Squibb June 2006 - May 2011
sanofi-aventis June 2004 - May 2006
Skills
GCP, Clinical Trials, Molecular Biology, Pharmaceutical Industry, Pharmaceutical Sales, Clinical Monitoring, Clinical Research, CTMS, Oncology, Hematology, Hepatitis C, Multiple Myeloma, Hemophilia, Melanoma, ICH-GCP, CRO, Clinical Development, Protocol, Therapeutic Areas
Education
Budapesti Corvinus Egyetem 2002 — 2004
postgraduate degree, Marketing
Kossuth Lajos University, Debrecen 1991 — 1996
Master of Science (MSc), Molecular Biology
TRIAL MASTERS CRA course
PSI CRO AG May 2015 - Present
inVentive Health August 2014 - April 2015
Theorem Clinical Research July 2012 - February 2014
Theorem Clinical Research September 2011 - July 2012
Omnicare Clinical Research June 2002 - May 2011
StarComm June 2000 - July 2001
Healthcare Liability Group October 1998 - March 2000
Skills
CRO, Project Management, Clinical Monitoring, GCP, Multiple Project..., Clinical Trials, CTMS, Clinical Development, Clinical Data Management, ICH-GCP, EDC, Regulatory Submissions, Therapeutic Areas, Drug Development, Inform, Pharmacovigilance, Protocol, Oncology, Medical Writing, Regulatory Affairs, 21 CFR Part 11, Sop, SOP
Education
Framingham State College 1981 — 1987
Bachelor of Arts (B.A.), Economics
Framingham State College
BA Economics
PSI CRO AG April 2014 - Present
Quintiles August 2006 - April 2014
MD Anderson Cancer Center March 2005 - August 2006
Skills
Project Management, Clinical Research, Clinical Trials, Clinical Supervision, Clinical Monitoring, Nursing, Registered Nurses, Nursing Management, Pediatric Nursing, Certified Pediatric..., certified oncology nurse, Oncology, Clinical Development, GCP, Biotechnology, CRO, CTMS, ICH-GCP, EDC, Pharmaceutical Industry, Clinical Data Management, Regulatory Submissions, Drug Development, Therapeutic Areas, SOP
Education
The University of Texas Health Science Center at Houston 2003 — 2006
Master of Science in Nursing Clinical Research Management, Registered Nursing/Registered Nurse
University of Texas School of Nursing Houston 2003 — 2005
MSN, Clinical Research Management
The University of Texas Health Science Center at Houston 1980 — 1982
BSN, Registered Nursing/Registered Nurse