RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.)
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RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) Employees
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2014 - Present
Skyline Medical Inc. September 2013 - May 2014
Reglera October 2012 - June 2013
Zimmer Spine June 2007 - April 2012
Zimmer Spine February 2003 - June 2007
Beckman Coulter May 2000 - February 2003
Beckman Coulter August 1991 - May 2000
Skills
Risk Management, Medical Devices, FDA, CAPA, Supplier Development, Product Specification, Regulatory Affairs, MRB, Quality Control, V&V, Quality System, Validation, ISO 13485, ISO, GMP, Quality Systems Design, Sop, FMEA, Quality Assurance, IQ, Manufacturing, Biotechnology, ISO 14971, Product Development, Design Control, 21 CFR Part 11, R&D, Quality Auditing, Testing, Design of Experiments, Sterilization, Software Documentation, Design for Manufacturing, Change Control, 21 CFR, SOP
Education
University of Minnesota-Twin Cities 1982 — 1988
B.S., Microbiology
St. Jude Medical March 2012 - Present
ev3 June 2008 - March 2012
St. Jude Medical February 2006 - June 2008
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2001 - February 2006
Empi June 2000 - June 2001
Skills
Clinical Trials, Medical Devices, Clinical Research, Clinical, FDA
Education
Bemidji State University 1979 — 1983
Bachelor of Science, Health/Biology
American Medical Systems December 2013 - Present
Boston Scientific April 2012 - December 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) November 2000 - March 2012
Empi January 1996 - November 2000
Skills
Medical Devices, Microsoft Office, Product Development, Strategic Planning, Project Management, Regulatory Affairs, FDA, Regulatory Submissions, Global Regulatory..., ISO 13485, GMP, Strategy, CAPA, Cross-functional Team...
Education
University of Minnesota-Twin Cities 1990 — 1995
Bachelor of Science (BS), Chemistry
St. Jude Medical June 2015 - Present
Be The Match operated by National Marrow Donor Program November 2013 - June 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) August 2012 - November 2013
Bath & Body Works July 2009 - June 2012
Blissful Bath May 2008 - November 2009
Maggie Moo's Ice Cream and Treatery May 2007 - May 2008
Skills
Medical Devices, Healthcare, Customer Service, Team Leadership, Clinical Research, Sales, GCP, Clinical Data Management, Clinical Trials, Nursing, Hospitals, Oncology, Pharmaceutical Industry
Education
St. Catherine University
Bachelor of Science (B.S.), Nursing
Upsher-Smith Laboratories October 2014 - Present
Covidien June 2012 - October 2014
Torax Medical, Inc. June 2011 - July 2012
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2007 - April 2011
Allina Hospitals & Clinics- Unity Hospital November 2000 - March 2007
Skills
Medical Devices, Clinical Trials, PMA, Clinical Research, FDA, GCP, Clinical Development, CTMS, Regulatory Affairs, EDC, CRO, Regulatory Submissions, Biotechnology
Education
Concordia University-St. Paul 2004 — 2006
Bachelors of Arts in Marketing and Management
Boston Scientific December 2014 - Present
Boston Scientific February 2008 - November 2014
Boston Scientific March 2004 - January 2008
Boston Scientific April 2003 - February 2004
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2001 - 2003
Aveda 1999 - 2001
Bahamas Ministry of Education 1994 - 1997
Education
University of St. Thomas
Bachelor of Arts (BA), Chemistry
University of Minnesota-Twin Cities
Graduate Studies, Organic Chemistry
Boston Scientific August 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2012 - May 2013
University of North Dakota June 2009 - August 2011
DragonTech September 2007 - May 2009
Minnesota State University Moorhead January 2005 - May 2009
Education
The University of North Dakota School of Medicine and Health Sciences 2009 — 2011
Masters, Biochemistry & Molecular biology
Minnesota State University, Moorhead 2004 — 2009
Bachelors, Biology, Chemistry
PatientPoint® 2013 - 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2011 - 2013
Contura Inc 2010 - 2011
Contura Inc 2006 - 2009
aCROnordic A/S 2003 - 2006
aCROnordic A/S 2003 - 2004
Novo Nordisk 2000 - 2002
Spadille Aps 1999 - 2000
Skills
Clinical Development, Regulatory Affairs, Medical Devices, Clinical Trials, Pharmaceutical Industry, Drug Development, CTMS, Biostatistics, Business Development, Project Management, Diabetes, Biotechnology, GCP, FDA, Clinical Research, Lifesciences, CRO, Regulatory Submissions, Dermatology, Clinical Data Management, Commercialization, 21 CFR Part 11, Validation, Protocol, ISO 13485, Health Economics, Sop, R&D, Cross-functional Team..., Biopharmaceuticals, Clinical Study Design, Life Sciences
Education
IE (Instituto de Empresa) 2006 — 2007
Executive MBA
1998 — 1999
Mathematics
Universitat Politècnica de Catalunya 1995 — 1999
MSc, Mathematics
Insight Advisor Group October 2011 - Present
PPD 2012 - 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2008 - October 2011
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2007 - 2008
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2004 - 2007
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2002 - 2004
Skills
Medical Devices, FDA, Lifesciences, Clinical Trials, Regulatory Affairs, Clinical Research, Strategic Planning, Program Management, Clinical Data Management, Quality Assurance, Start-ups, Research, Writing, 21 CFR Part 11, Strategy, Clinical Development, Healthcare
Education
University of Minnesota-Twin Cities 2000 — 2002
MPH, Epidemiology
St. Olaf College 1991 — 1995
BA, Chemistry
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) April 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) November 2010 - March 2013
US Air Force April 2009 - April 2010
US Air Force May 2008 - April 2009
US Air Force January 2007 - May 2008
US Air Force July 2005 - January 2007
US Air Force ROTC / University of Minnesota June 2002 - July 2005
US Air Force June 2001 - June 2002
US Air Force June 1999 - June 2001
US Air Force July 1998 - June 1999
Skills
Troubleshooting, Security, ITIL, Military, Integration, Program Management, Active Directory, Management, Switches, Information Assurance, Microsoft Office, Team Leadership, Networking, Leadership, Servers, Computer Security, Telecommunications, Software Installation, Project Planning, Network Administration, SharePoint, Dell PowerEdge Servers, VMware ESX, Citrix XenApp
Education
Troy University in Montgomery 1999 — 2000
MBA, Business
Mount Olive College 1992 — 1997
Accounting
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) August 2009 - Present
City of Bloomington, MN June 2001 - August 2014
Rimage Corporation June 2006 - August 2009
Skills
Management, Medical Devices, Cross-functional Team..., ERP, CRM, Vendor Management, Validation, Life Sciences, Start-ups, Biotechnology, Clinical Trials, Process Improvement
Education
St. Cloud State University 2011 — 2015
Master's Degree, Applied Clinical Research
University of Minnesota-Twin Cities 2002 — 2006
Bachelor of Science (B.S.), Genetics, Cell Biology and Development
Normandale Community College 2001 — 2002
PSEO, Math and Sciences
Boston Scientific July 2014 - Present
Boston Scientific July 2013 - July 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2012 - July 2013
Mocon February 2012 - September 2012
Fairview Health Services July 2009 - February 2012
Woodwinds Hospital January 2009 - July 2009
Skills
Clinical Research, Healthcare, Medical Writing, Clinical Trials, Hospitals, Cancer, GCP, PCR, CTMS, Clinical Monitoring, EDC, Pediatrics, Protocol, Oncology, Medical Devices, Clinical Development, Life Sciences
Education
University of Minnesota-Twin Cities 2006 — 2009
Bachelor of Science (B.S.), Biology, General
The College of St. Scholastica 2005 — 2006
Osprey Medical December 2013 - December 2013
St. Jude Medical September 2012 - December 2013
St. Jude Medical May 2010 - September 2012
St. Jude Medical May 2005 - May 2010
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2003 - 2005
Arthur Shuster Inc 2000 - 2002
Smiths Medical 1987 - 1999
Skills
CTMS, FDA, Clinical Trials, Medical Devices, Clinical Monitoring, Cardiology, GCP, Clinical Research, EDC, CRO, Clinical Development, Clinical Data Management, Regulatory Submissions, Protocol, Clinical Study Design, Regulatory Affairs, Sop
Education
Century College
Hill Murray High School
Capella University 2012 - Present
Coaching 2007 - 2012
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2007 - 2011
Minneapolis Heart Institute Foundation 1984 - 2006
Minneapolis Heart Institute 1987 - 1995
Skills
Organizational..., New Business Development, People Management, Strategic Planning, Team Building, Problem Solving, Mentoring, Financial Management, Operations Management, Program Development, Leadership, Business Development, Management, Customer Service, Clinical Research, Managerial Finance, Program Management, Medical Devices, Strategy, Healthcare, Coaching, Employee Relations, Human Resources, Community Outreach, Research, Budgets, Team Leadership, Policy, Project Planning, Leadership Development, Personal Development, Recruiting, Staff Development, Nonprofits, Public Speaking, Contract Negotiation, Time Management, Training, Organizational..., Fundraising, Executive Coaching, Change Management, Healthcare Management, Cross-functional Team..., Management Consulting, Performance Management, Consulting, Process Improvement, Entrepreneurship, Organizational...
Education
St. Catherine University
Certificate, Executive Women's Leadership Roundtable
Adler Graduate School
Certificate, Professional Life Coaching
University of Saint Thomas
Mini MBA, Medical Technology Management
University of Saint Thomas
MBA, Management
University of Wisconsin-La Crosse
Master of Science, Adult Fitness/Cardiac Rehabilitation
College of St. Benedict
Bachelor of Science, Nursing
Apex International December 2013 - Present
Promed Pharma May 2008 - December 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2005 - May 2008
ComplianceNet October 2001 - September 2005
Protein Design Labs May 1997 - October 2001
Amgen July 1991 - March 1996
Skills
Quality System, CAPA, FDA, Validation, ISO 13485, GMP, Medical Devices, Quality Assurance, Microbiology, Sop, SOP, Quality Control, Computer System..., Biotechnology
Education
Colorado State University 1984 — 1988
B.S., Microbiology
Merge eClinical March 2015 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) April 2013 - January 2015
PharmaVigilant July 2009 - November 2012
Maio Healthcare Consulting Solutions January 2009 - July 2009
inVentiv Health March 2006 - December 2008
IMS Health 2005 - 2006
Healthstar Communications 2003 - 2005
iPhysicianNet 1999 - 2003
NDC Health (now Wolters Kluwer) 1987 - 1999
Skills
Business Development, Lead Generation, Analytics, Pharmaceutical Industry, Competitive Intelligence, Strategy, Pharmaceutics, Business Planning, CRM, Strategic Planning, Cross-functional Team..., Leadership, SaaS, Clinical Trials, Market Research, Lifesciences, Medical Devices, New Business Development, Biotechnology, Program Management, Management, Product Development, Project Management, Solution Selling, Forecasting, EDC, Healthcare, Sales, Life Sciences
Education
Southern Illinois University, Edwardsville
MBA
Villanova University
BA
Coloplast August 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2006 - August 2013
i3 Research January 1999 - January 2006
Datalog January 1997 - January 1999
Skills
FDA, Clinical Trials, Clinical Development, Medical Devices, Regulatory Affairs, Clinical Research, Lifesciences, NDA, CRF design, CTMS, Drug Development, Biomarkers, Biostatistics, GCP
Education
Concordia College
Bachelor's degree, Organizational Leadership
Medtronic December 2011 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) February 2008 - November 2011
Abbott Northwestern Hospital May 1987 - June 2000
Skills
FDA, Medical Devices, CTMS, Protocol, Cardiology, Clinical Development, Clinical Monitoring, Clinical Research, Sop, EDC, Clinical Study Design, Clinical Trials, Regulatory Submissions, Biotechnology, Life Sciences, Management, CRO, ISO 13485, Clinical Data Management, GCP, Project Management
Education
The College of St. Scholastica 1979 — 1983
B.A., Medical Technology
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 1998 - Present
Skills
Medical Devices, Lifesciences, Clinical Trials, Clinical Development, Biotechnology, Clinical Research, FDA, ISO 13485, Regulatory Affairs, Biostatistics, GCP, Validation, CRO, Clinical Data Management, Regulatory Submissions, Pharmaceutical Industry, Neuroscience, Cardiology, Health Economics, Hospitals, Sop, Clinical Study Design, Healthcare, Data Management, Design Control, Clinical Monitoring, Protocol, R&D, Quality System, CAPA, Infectious Diseases
Education
The University of Texas Health Science Center at Houston
PhD, Epidemiology
University of Minnesota-Twin Cities
MPH, Epidemiology
eMgine HealthLogics February 2014 - February 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2008 - January 2014
Skills
Clinical Development, Medical Devices, Executive Management, Biostatistics, Health Economics, FDA, Clinical Trials, Strategic Consulting, Regulatory Submissions, Protocol, Lifesciences, CRO, CTMS, Regulatory Affairs, Biotechnology, Commercialization, Life Sciences, Cross-functional Team..., Clinical Research, Product Development
Education
Florida State University
MS, Statistics
St. Olaf College
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) January 2011 - February 2013
Skills
Clinical Trials, Regulatory Affairs, Medical Devices, Clinical Research, GCP, CRO, EDC, Clinical Data Management, FDA, CTMS, Clinical Development, Biotechnology, Sop, Protocol, Lifesciences, Life Sciences
Education
University of Minnesota-Twin Cities 2005 — 2010
Bachelor of Science (BS), Biomedical/Medical Engineering
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2012 - Present
Outcome Sciences October 2010 - January 2012
MedNet Solutions 2003 - October 2010
Orphan Medical 2002 - 2003
Phycom 2000 - 2002
Vida Healthcare 1999 - 2000
Patient Infosystems 1996 - 1999
ParaNatal Care of America 1992 - 1995
Janssen Pharmaceutica 1989 - 1992
Muro Pharmaceuticals 1985 - 1989
Skills
Clinical Trials, CTMS, Medical Devices, Biotechnology, Clinical Research, EDC, Clinical Development, FDA, Healthcare, Lifesciences, Start-ups, Cardiology, Regulatory Affairs, GCP, Clinical Data Management, Business Development, Data Management, New Business Development, Infectious Diseases, Product Development, Strategic Planning, 21 CFR Part 11, Protocol, Pharmacovigilance, Clinical Monitoring, Leadership, CRO, Pharmaceutical Industry, Regulatory Submissions, Management, Pharmaceutical Sales, Medical Writing, Urology, Project Management, R&D, Health Economics, Diabetes, Cancer, Therapeutic Areas, Cross-functional Team..., Commercialization, Strategic Partnerships, Competitive Analysis, Oncology, Strategy, Selling, Market Research, Sales Process, Sales, Life Sciences
Education
University of Minnesota-Twin Cities 1982 — 1984
BA, History
Beloit College 1981 — 1982
St. Johns Prep 1979 — 1980
Eden Prairie 1977 — 1978
CJ Communications January 1995 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2007 - March 2011
Search Institute March 1999 - May 2007
Featherlite Exhibits January 1997 - March 1999
On-Site Learning Institute January 1994 - January 1997
Skills
Marketing Communications, Newsletters, Direct Mail, Copywriting, Social Media, Brand Development, Fundraising, Graphic Design, Marketing, Creative Direction, Copy Editing, Adobe Creative Suite, Event Planning, Marketing Strategy, Advertising, Integrated Marketing, Content Development, Public Relations, Content Management, Branding & Identity, Strategic Planning, Social Media Marketing, Strategic Communications, Art Direction, Photoshop, Photography, Content Strategy, Social Networking, Non-profits, Editing, Blogging, Web Content, Event Management, Brand Management, Typography, Proposal Writing, SEO, Online Marketing, Market Research, Press Releases, Collateral, Corporate Branding, Nonprofits, Community Outreach, Volunteer Management, Proofreading, Email Marketing, Brochures, Creative Writing, Publishing
Education
University of Minnesota-Twin Cities 1988 — 1992
B.A., Mass Communications and Advertising
University of Minnesota-Twin Cities
Courses in Professional M.A. Strategic Communications
Genentech December 2014 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) August 2012 - November 2014
Genentech July 2011 - August 2012
Medtronic, Inc February 2009 - July 2011
Novartis October 2008 - January 2009
Monogram Biosciences September 2007 - October 2008
Vandrebilt Univ, Medical Center August 2005 - September 2007
vanderbilt 2005 - 2007
Skills
Biostatistics, Clinical Study Design, Clinical Trials, Clinical Development, Biotechnology, Life Sciences, Pharmaceutical Industry, Oncology, GCP, FDA, CRO, Clinical Data Management, Medical Devices
Education
University of Minnesota-Twin Cities 2003 — 2005
MSc, Biostatistics
National Taiwan University 1999 — 2001
MSc, Health Policy and Management
Cardiovascular Systems, Inc. February 2014 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2012 - February 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) July 2010 - May 2012
RCRI, Inc. May 2006 - July 2010
RCRI, Inc. April 2004 - April 2006
3M Pharmaceuticals May 2003 - April 2004
3M Pharmaceuticals 1995 - 1999
The Ohio State University 1984 - 1990
Skills
Clinical Trials, Medical Affairs, Clinical Operations, Clinical Development, FDA, Clinical Research..., Healthcare, GCP
Education
The Ohio State University 1984 — 1989
MS, Biochemistry/Molecular Biology
Potsdam College 1980 — 1984
BA, Biology and Chemistry
QiG Group March 2015 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) January 2015 - March 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) February 2012 - January 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) February 2011 - February 2012
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2008 - February 2011
Minnesota Department of Health December 2006 - June 2008
Skills
Clinical Research, Clinical Trials, FDA, Medical Devices, GCP, Clinical Development, Regulatory Submissions, Biostatistics, CRF design, Clinical Data Management, Clinical Monitoring, Clinical Study Design, CRO
Education
Arizona State University
Bachelor of Science (BS), Biology and Society Major, Spanish Minor
University of Minnesota-Twin Cities
Master of Public Health (MPH), Epidemiology
United Health Care April 2015 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) February 2014 - April 2015
St. Jude Medical July 2009 - February 2014
Carlson Wagonlit Travel June 2007 - March 2009
Piper Jaffray & Co January 2006 - May 2007
Eaton Hydraulics August 2004 - January 2006
Petters Group November 2003 - June 2004
Thermo King Corporation March 2000 - November 2003
Anderson Consulting July 1998 - March 2000
Skills
Process Improvement, Project Management, Training, Microsoft Excel, Time Management, Customer Service, Budgets, Project Planning, Program Management, Public Speaking, Internal Communications, Human Resources, PowerPoint, Large-scale Event..., Travel Management, SharePoint, Organization, Visio, Outlook, Microsoft Office, Microsoft Word, Clindex
Education
University of Phoenix 2009 — 2011
MBA, Business Administration, Management and Operations
University of Phoenix 2004 — 2009
Bachelors, Business Management
Villanova University 2004 — 2004
Certficate, Project Management
Minnesota School of Business 1982 — 1983
Assoc, Computer Programming & Operations
PAREXEL January 2014 - July 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) July 2013 - October 2013
G&G Consulting 1997 - 2013
United Health Care September 2012 - December 2012
Wells Fargo February 2012 - August 2012
RBC Dain 2007 - 2008
Astellas Pharma January 2006 - December 2006
Boston Scientific 2005 - 2006
Skills
Business Intelligence, SAS, Analytics, Data Mining, Portfolio Management, SAS programming, Risk Management, Business Analysis, Data Analysis, Financial Risk, Financial Modeling, Data Management, Banking, Financial Services, Statistics, Logistic Regression, Testing, Unix, Analysis, Training, Clinical Trials, Data Warehousing, Predictive Modeling, Databases, Quantitative Analytics, SQL, Consulting
Education
Arizona State University - W. P. Carey School of Business 1993 — 1995
M.S., Statistics
Creighton University 1989 — 1992
B.S. in Mathematics, Math/Statistics
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) February 2014 - Present
St. Jude Medical April 2010 - January 2014
Zimmer Spine April 2006 - April 2010
Biomet 3i July 2004 - April 2006
Skills
PMA, Design Control, ISO 13485, FDA, Regulatory Affairs
Education
University of Minnesota-Twin Cities 2000 — 2004
B.S.BME, Biomedical Engineering
American Medical Systems August 2013 - Present
American Medical Systems April 2012 - August 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2011 - April 2012
RCRI, Inc. December 2010 - June 2011
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2008 - December 2010
i3 Research November 2006 - May 2008
Medtronic October 2004 - November 2006
Minneapolis Clinic of Neurology March 2003 - October 2004
Skills
Clinical Trials, GCP
Education
Concordia University-St. Paul 2010 — 2011
B.A., Organizational Management & Leadership
Dunwoody College of Technology
UCare April 2014 - Present
UCare October 2012 - April 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) November 2011 - November 2012
UCare Minnesota 2008 - January 2012
i3 Research March 1999 - June 2008
Washington State Hospital Association 1997 - 1999
UnitedHealth Group 1996 - 1997
VA Medical Center 1989 - 1996
Skills
Clinical Research, Research, Program Development, Data Analysis, Hospitals, Lifesciences, Leadership, Management, Nonprofits, HIPAA, Strategic Planning, PowerPoint, Inpatient, EHR, Public Health, Microsoft Word, Statistics, Healthcare Management, Policy, Healthcare, Disease Management, Community Outreach, Diabetes, GCP, Project Management
Education
University of Minnesota - Carlson School of Management
MA, Industrial Relations
University of Minnesota-Twin Cities
B.S., Family Social Science
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) January 2013 - Present
Empi January 2011 - January 2013
DJO January 2009 - January 2013
DJO Global January 2009 - January 2011
3M October 2008 - January 2009
CHS April 2008 - August 2008
Skills
Medical Devices, Leadership, Marketing, Sales, Strategy, Business Development, Marketing Strategy, Microsoft Office, Analysis, Healthcare, Market Research, Marketing Communications, Clinical Trials, Product Launch, Cardiology, Teaching, Recruiting, Orthopedic, CRM, Strategic Planning, Customer Service
Education
University of Northwestern - St. Paul 2004 — 2008
Bachelor's Degree, Double Major: Business Marketing, Bible
New Life Academy
Henry Sibley High School
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2015 - Present
Antares Pharma Inc. March 2013 - March 2015
Biodaptive LLC September 2011 - March 2013
Heraeus March 2003 - July 2011
Heraeus July 2007 - February 2011
Heraeus March 2003 - July 2007
Merck Sharp & Dohme December 2001 - January 2002
Merck Sharp & Dohme August 2000 - December 2001
Skills
Quality System, Quality Management, CAPA, Medical Devices, FDA, ISO 13485, Quality Auditing, GMP, Project Management, Validation, SPC, ISO 14971, Change Control, Design Control, Supplier Quality, Regulations, ISO, Quality Assurance, Root Cause Analysis, CMDR, 21 CFR, 21 CFR Part 11, Process Improvement, FMEA, Auditing, Biomedical Engineering, V&V, Strategic Planning, MDD93/42/EEC, 510k, Document Management, Software Documentation, Six Sigma, DMAIC, Regulatory Intelligence, STED
Education
St. Cloud State University 2012 — 2015
Master's Degree, M.S. Regulatory Affairs and Services
Universidad Autonoma Metropolitana 1993 — 1999
BS, Industrial Biochemical Engineer
Spectranetics January 2015 - September 2015
Covidien November 2012 - January 2015
Covidien August 2010 - November 2012
Boston Scientific September 2006 - August 2010
Boston Scientific January 2004 - September 2006
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2002 - 2003
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2001 - 2002
Skills
FDA, Clinical Trials, Medical Devices, Sop, Clinical Development, Regulatory Affairs, 21 CFR Part 11, Clinical Research, GCP, Regulatory Submissions, Clinical Monitoring, EDC, CRO
Education
St. Cloud Technical College 2007 — 2008
EMT(B), Emergency Medical Technician
Metropolitan State University 1999 — 2002
Bachelors, Information Technology
Regulatory and Clinical Research Institute, Inc February 2013 - Present
RCRI March 2012 - February 2013
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) November 2011 - March 2012
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2007 - November 2011
Lifecore Biomedical, Inc January 2000 - January 2006
Minntech Corporation January 1996 - January 2000
Owl Scientific January 1995 - January 1996
Amicon, Inc January 1988 - January 1995
W.R Grace & Co January 1987 - January 1988
Owens Corning Fiberglas 1985 - 1987
Skills
Medical Devices, FDA, CAPA, ISO 13485, Strategic Planning, Clinical Research, GMP, Regulatory Affairs, Quality System, Clinical Development, Regulatory Submissions, Manufacturing, HPLC, Product Development, GLP, Quality Assurance, V&V, 21 CFR Part 11, Validation, Biotechnology, Clinical Trials, Sop, Lifesciences, R&D, CRO, ISO 14971, Protocol, Clinical Data Management, Pharmaceutical Industry, Technology Transfer, ISO, CTMS, EDC, Regulatory Requirements, Cross-functional Team..., Analytical Chemistry, Health Economics, Clinical Study Design, Clinical Monitoring, PMA, Design Control, Commercialization, Biopharmaceuticals, GCP
Education
University of Massachusetts at Lowell 1994 — 1998
MBA, Project Management
Northwestern University 1981 — 1985
Ph.D, Chemistry
Northwestern University
M.S, Chemistry
Gustavus Adolphus College 1975 — 1979
B.A, Chemistry
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) April 2015 - Present
WuXi AppTec July 2014 - April 2015
ISOTC 194 2000 - 2015
ISO TC 194 1998 - 2015
ISO TC 194 1998 - 2015
ISO TC 194 1998 - 2015
WuXi AppTec January 2010 - July 2014
WuXi AppTec January 2008 - January 2010
AppTec, Inc. January 2007 - January 2008
AppTec, Inc. January 2006 - January 2007
Skills
Project Management, GLP, Cytotoxicity, Medical Devices, Lifesciences, In Vitro, In Vivo, Assay Development, Laboratory, FDA, Biotechnology, Biopharmaceuticals, Technology Transfer, Validation, Sop, Drug Discovery, Clinical Development, GMP, Commercialization, CRO, Drug Development, Immunology, Clinical Trials, Pharmaceutical Industry, Regulatory Affairs, R&D, Vaccines, ISO 13485, Infectious Diseases, CAPA, Regulatory Submissions, Chemistry, Oncology, IND, Molecular Biology, Biologics, 21 CFR Part 11, Microbiology, V&V, Quality System, Life Sciences, Management, Cross-functional Team..., Strategy, Leadership, Product Development, SOP, Strategic Planning, Cell Culture, ELISA
Education
University of St. Thomas 2011 — 2014
Master of Business Administration (M.B.A.), Executive Management
University of Minnesota-Twin Cities 1992 — 1996
BS, Microbiology
Stratasys November 2014 - Present
Stella & Dot / Younique March 2014 - Present
GE Power & Water September 2014 - November 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) November 2011 - January 2014
Beckman Coulter July 2010 - November 2010
Skills
Employee Engagement, Talent Management, Employee Relations, HRIS, Succession Planning, Human Resources, Workforce Planning, Performance Management, Deferred Compensation, HR Policies, Recruiting, Onboarding, Compensation & Benefit, Customer Service, Talent Acquisition, Technical Recruiting, Interviews
Education
Saint Mary's University of Minnesota 2009 — 2011
MA, Human Resource Management
University of Minnesota-Twin Cities 2003 — 2007
BA, Psychology
Driver's Education Inc. October 2010 - Present
Driver's Education, Inc. October 2010 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2006 - October 2010
Twin Cities Orthopedics March 2001 - May 2006
Skills
Healthcare, Clinical Research, Medical Terminology, EMR, HIPAA, Medical Billing, Medical Records, Epic Systems, Data Entry, Microsoft Word, PowerPoint, Public Speaking, Patient Advocacy, Physician Relations, Orthopedic, Surgery, Patient Education, Research, Medical Education
Education
Southern New Hampshire University 2012 — 2016
Bachelor of Business Administration (B.B.A.), Business Administration/Human Resources
North Hennepin Community College 1993 — 1995
Associate of Arts (A.A.)
Be The Match operated by National Marrow Donor Program January 2012 - Present
SAVE February 2006 - May 2014
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2008 - January 2012
Medtronic October 2004 - February 2008
Fletcher Allen Health Care December 2001 - April 2004
Porter Medical Center December 2001 - April 2004
Fletcher Allen Health Care January 1982 - December 2001
Bassett Healthcare July 1975 - December 1982
Skills
Medical Devices, FDA, Healthcare, Strategy, Regulatory Affairs, Biotechnology, Leadership, Clinical Trials, Strategic Planning, Medicine, Hospitals
Education
Hartwick College 1978 — 1980
B.S., Medical Technology
PAREXEL International Inc. April 2014 - Present
RCRI, Inc February 2010 - February 2013
MedNet Solutions June 2008 - January 2010
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2007 - June 2008
Medtronic October 2006 - June 2007
Skills
EDC, Clinical Research
Education
University of Minnesota-Twin Cities 2004 — 2006
Bachelor of Science (B.S.), Biology
Hibbing Community College-A Technical and Community College 1999 — 2001
Associate of Arts (A.A.), Pre-Medicine/Pre-Medical Studies, 3.8
Rebiotix July 2015 - Present
Rebiotix Inc September 2012 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) May 2002 - September 2012
Baxter BioSurgery (formerly Synovis Life Technologies) November 1997 - May 2002
Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, Lifesciences, ISO 13485, Quality System, Healthcare, Neuroscience, Strategic Planning, Cardiology, Biomedical Engineering, Program Management, Quality Assurance, Start-ups, Clinical Data Management, Regulatory Submissions, Clinical Study Design, Regulatory Affairs, Clinical Development, CTMS, GCP, Biotechnology, Cross-functional Team...
Education
Loyola University Chicago
Bachelor of Science in Nursing (BSN) cum laude
University of Minnesota-Twin Cities
Master of Healthcare Administration
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) March 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) April 2012 - March 2013
Children's Mercy Hospital November 2010 - April 2012
Minnesota Department of Health May 2007 - November 2010
Skills
Epidemiology, SAS, Public Health, Data Analysis, Research, Program Evaluation, Infectious Diseases, Statistics, Biostatistics, Research Design, Literature Reviews, Clinical Research, Global Health
Education
University of Minnesota-Twin Cities 2005 — 2007
Masters, Public Health - Epidemiology
University of St. Thomas 2001 — 2005
Bachelor of Arts, Biology
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) December 2014 - Present
Mar Vista Family Center September 2013 - Present
Zimmer Spine November 2008 - August 2012
St. Olaf College September 2005 - May 2008
Minnesota Safety Council, Inc. May 2007 - August 2007
Minnesota Safety Council, Inc. May 2006 - August 2006
Skills
Research, Writing, Public Speaking, PowerPoint, ArcGIS, Stata, Customer Service, Microsoft Office, Microsoft Excel, Policy Analysis, Program Evaluation, Grant Writing, Community Outreach, Fundraising, Editing, Volunteer Management, Public Policy
Education
University of Southern California 2012 — 2014
Master of Public Policy, Public Policy Analysis
St. Olaf College 2004 — 2008
B.A., English, Political Science
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) July 2011 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) September 2005 - June 2011
Skills
Clinical Development, Medical Devices, SAS programming, Clinical Research, Statistical Modeling, Clinical Trials, Clinical Study Design, Regulatory Submissions, Statistical Data..., Regulatory Guidelines, Statistical Consulting, Biostatistics, Clinical Data Management, Statistics, GCP, FDA, EDC
Education
University of Minnesota-Twin Cities 2003 — 2005
Master's, Statistics
Augsburg College 1998 — 2002
Bachelor's, Mathematics
Paalalinna Gümnaasium 1993 — 1997
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) October 2007 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) August 2001 - Present
Skills
Medical Devices, FDA, Clinical Trials, Clinical Research, Team Leadership, Microsoft Office, Troubleshooting, Windows, Active Directory, Protocol, Data Management, Quality System, Healthcare, Quality Assurance, Software Documentation, Process Improvement, Vendor Management, Access, Validation
Education
Capella University 2004 — 2007
Information Technology
Heald College 1998 — 2000
Associates, IT
Jonti-Craft August 2013 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) August 2012 - May 2013
Deloitte August 2011 - June 2012
Bennett Office Technologies March 2010 - August 2011
Kingland Systems November 2008 - May 2009
Skills
Windows Server 2012 R2, Windows Server 2008 R2, Windows Server 2003, Active Directory, Hyper-V, VMware vSphere, SQL Server Management..., Microsoft Access, DHCP, DNS, Windows Server Update..., Kaspersky Security..., Dell AppAssure, Windows 8.1, Windows 7, Troubleshooting, Hardware, Laptops, Operating Systems, Microsoft Exchange, Windows Server, Computer Hardware, SharePoint, Printers, Network Security, Networking, Technical Support, Windows 10, Windows XP, Java, C++, SQL, VB.NET, Microsoft Word, Microsoft Excel, Visual Studio, Dell KACE, Phone System..., Mobile Devices, Microsoft Office, Customer Service, Information Technology, Leadership
Education
Iowa State University - College of Business 2005 — 2009
Bachelor's Degree, Business Management Information Systems
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) June 2005 - Present
Skills
Clinical Trials, Clinical Research, GCP, CTMS, Medical Devices, Clinical Development, Clinical Monitoring, Healthcare, EDC, Psychology, FDA, CRO, Life Sciences, Biotechnology
Education
The University of North Dakota 1999 — 2004
Bachelors in Psychology and Physical Education with Minor in Coaching
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) October 2012 - Present
Cathie Rutherford Consulting August 2008 - Present
Medtronic through Robert Half Legal 2011 - 2011
Eleos Inc. 2006 - 2008
Orphan Medical 1996 - 2005
Skills
Regulatory Affairs, Project Management, Clinical, Microsoft Office, Microsoft Excel, Microsoft Word, Annual Reports, Data Management, Research, Team Building, Journal Entries, PowerPoint, Sop, Outlook, Management, Lifesciences, Pharmaceutical Industry, Clinical Trials, Clinical Research, Oncology, Medical Devices, Cross-functional Team..., Process Improvement, Team Leadership, eCTD, Quality System, CTMS, GCP, Protocol, SOP, Life Sciences
Education
St. Olaf College
BA, Sociology, Urban Studies, Math
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) July 2015 - Present
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) January 2015 - July 2015
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2013 - 2015
Boston Scientific June 2011 - November 2012
Boston Scientific 2001 - 2011
Abbott Laboratories 1994 - 2001
Skills
FDA, Clinical Trials, Medical Devices, Clinical Development, Clinical Research, GCP, Validation, Biostatistics, EDC, Regulatory Submissions, SAS, Protocol, CAPA, Sop, Clinical Monitoring, Cardiology, Clinical Study Design, Quality System, SOP, CRO, Health Economics
Education
North Carolina State University
MS, Statistics
St. Cloud State University
BA, Statistics and Mathematics
HRFreeAgent, LLC January 2015 - Present
Hennepin County Medical Center April 2008 - February 2015
HRFreeAgent February 2001 - December 2008
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) December 2003 - June 2006
Hudson Medical Center July 1998 - February 2001
Kneetogs June 1990 - September 1994
Skills
Healthcare, Employee Relations, Performance Management, Deferred Compensation, Clinical Research, Talent Acquisition, Recruiting, Onboarding, Employee Benefits, Human Resources, Performance Improvement, Workforce Planning, Organizational..., Leadership Development, Strategy, Leadership, Management
Education
Saint Mary's University of Minnesota 1994 — 1998
MA, HRD
University of Minnesota-Twin Cities
BA, Organizational Communication
Cardiovascular Systems Inc September 2013 - Present
Allina Hospitals & Clinics July 2012 - September 2013
American Medical Systems August 2011 - July 2012
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) January 2008 - August 2011
Hutchinson Technology Inc. 2005 - 2008
Skills
Medical Devices, Healthcare, Urology, Clinical Research, CTMS, GCP, Hospitals, Software Documentation, Healthcare Information..., Informatics, Data Management, FDA, Clinical Data Management, EHR
Education
The College of St. Scholastica 2010 — 2013
Master of Science (M.S.), Health Information Management
University of Minnesota-Duluth
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Steere and Associates 2007 - Present
AbbeyMoor Medical, Inc 2003 - 2007
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) 2000 - 2003
Raymedica 1998 - 2000
Raymedica 1998 - 1998
Urologix 1996 - 1998
Urologix 1993 - 1996
R&D Systems 1991 - 1993
Abbott Northwestern Hospital 1986 - 1991
University of Minnesota 1985 - 1986
Skills
Clinical Trials, Clinical Monitoring, FDA, Medical Devices, Clinical Research, SOP, Regulatory Submissions, Medical Writing, Protocol, Therapeutic Areas, Biotechnology, Life Sciences
Education
University of Minnesota-Twin Cities
Bachelor of Science (BS), Microbiology
Univeristy of Minnesota
Master of Science (MS), Genetics
University of St. Thomas
Master of Business Administration (MBA), Marketing
RCRI, Inc. (Regulatory & Clinical Research Institute, Inc.) April 2008 - Present
3M Health Care and 3M Pharmaceutical Division April 2001 - April 2008
Laser Vision Centers, Inc. 1999 - 2001
Skills
Clinical Research, Clinical Trials, Team Management, Team Leadership, Nursing Management, Clinical Monitoring, Protocol, GCP, Clinical Study Design, CTMS
Education
Cardinal Stritch University 1995 — 1998
MBA
University of Wisconsin-Madison
Bachelor of Science in Nursing