Joann Pfeiffer, Drsc

Joann Pfeiffer, Drsc Email and Phone Number

Healthcare Innovation Catalysts @ Arizona State University
Joann Pfeiffer, Drsc's Location
Idaho Falls, Idaho, United States, United States
Joann Pfeiffer, Drsc's Contact Details

Joann Pfeiffer, Drsc work email

Joann Pfeiffer, Drsc personal email

n/a

Joann Pfeiffer, Drsc phone numbers

About Joann Pfeiffer, Drsc

Professor - Clinical Research Management, curriculum development, quality matter peer reviewer.Regulatory Affairs Consultant - interpretation and practical application of regulations and guidance. Clinical Trial Operations - comprehensive knowledge and experience of IND trials.Compliance Officer - assure business needs and regulatory requirements are properly balanced to achieve compliance without compromising business objectives.Product Manager - development of global CTMS applications, implementation & integration of systems.Provide training & coaching to all levels of management and study staff regarding FDAs expectations and management responsibilities. Regulatory Strategy - provide technical, strategic, and tactical advice to assist in the development of regulatory strategies for compliance with FDA regulations.Instructor/Guest Speaker - Regulatory Affairs/Clinical Trial Operations/Contract & Budget Negotiations and Management.Team leader with comprehensive knowledge and experience in the interpretation and practical application or federal regulations and regulatory and industry standards and guidelines.Unique combination of experience and education provides strategic insight to all levels involved with clinical trials, site development and management, site auditing and comprehensive reviews of documents and data, and advice and support of regulatory submissions.

Joann Pfeiffer, Drsc's Current Company Details
Arizona State University

Arizona State University

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Healthcare Innovation Catalysts
Joann Pfeiffer, Drsc Work Experience Details
  • Healthcare Innovation Catalysts
    Senior Consultant
    Healthcare Innovation Catalysts Jun 2023 - Present
  • Arizona State University
    Clinical Professor Clinical Research Management & Regulatory Science
    Arizona State University Mar 2014 - Present
    Phoenix, Arizona, United States
  • Arizona State University
    Sr. Director/Clinical Professor, Clinical Research Management & Regulatory Science Masters Programs
    Arizona State University Jun 2015 - Jul 2023
    Phoenix, Arizona
    Direct Graduate Clinical Research Management & Regulatory Science Programs; curriculum development; faculty oversight; program accreditation; coordinate online learning management system; program development; student acceptance; associate professor; authored multiple text books in the area of clinical research management including clinical trials operations, budgets and contracts, and complementary materials for education and training. National speaker on clinical trials contracts, clinical trial budgets, collaboration and communication between sites and sponsors/CROs, study start-up strategies, financial feasibility, and more. Expert witness/consultant for clinical research legal cases.
  • Arizona State University
    Senior Director & Clinical Professor Clinical Research Management & Regulatory Science Graduate Prog
    Arizona State University Jun 2015 - May 2023
    Greater Phoenix Area
  • Regulatory/Clinical Trials Consultant/Contractor
    Clinical Research Consultant
    Regulatory/Clinical Trials Consultant/Contractor Nov 2013 - Nov 2023
    Phoenix, Arizona Area
    Provide training and coaching to all levels of management regarding FDA, HIPAA, and Public Health Services regulations and guidelines. Provide clients with strategic, tactical, and technical advice to assist in the development of regulatory strategies for compliance with FDA regulations. Proficient in conducting audits and comprehensive reviews and analysis of documents and data pertaining to IND studies and study sites. Direct clinical trial operations.
  • George Washington University
    Adjunct Professor
    George Washington University Jul 2014 - Jun 2015
    Instructor clinical and regulatory research classes
  • Arizona State University College Of Nursing & Health Innovation
    Faculty Associate
    Arizona State University College Of Nursing & Health Innovation May 2014 - Jun 2015
    Phoenix
    Teach multiple courses in the Clinical Research Management Program. Curriculum development for online graduate courses.
  • Velos, Inc
    Product Manager/Compliance Officer
    Velos, Inc Oct 2010 - Feb 2013
    California
    VELOS Medical Informatics, Inc., Fremont, CA 2010 -
  • University Of Southern California
    Research Project Manager
    University Of Southern California Apr 2008 - Jul 2010
    UNIV. OF SOUTHERN CALIFORNIA, Los Angeles, CA Biomedical Informatics Senior Project Manager
  • Boling Clinical Trials
    Director
    Boling Clinical Trials Apr 2006 - Feb 2008
    Directing all aspects of the day-to-day operations of a medium-sized clinical trial business. Hiring, training, data and document management, recruitments, enrollment, budgets and contracts, compliance, regulatory, reporting, product accountability, policies and processes.
  • University Of Colorado Health Sciences Center
    Director Of Research
    University Of Colorado Health Sciences Center Oct 2000 - Mar 2006
    .
  • Colorado Dept. Of Public Health
    Program & Training Specialist
    Colorado Dept. Of Public Health Jan 1993 - Jan 2000
    Greater Denver Area
    Development and oversight of public and professional education programs for the State of Colorado in the following areas: diabetes, arthritis, and cardiovascular health. Manage state advisory committees and the development of state strategic plans.

Joann Pfeiffer, Drsc Skills

Clinical Trials Regulatory Submissions Ctms Regulatory Affairs Management Clinical Research Fda Program Management Project Management Pharmaceutical Industry Medical Devices Quality Assurance Biotechnology Sop Gmp Oncology Informatics Team Leadership Regulatory Requirements Cross Functional Team Leadership Performance Management Budgets Training Leadership Clinical Development Standard Operating Procedure U.s. Food And Drug Administration Clinical Trials Operations Management Auditing Analysis Gcp Computer System Validation Cro Clinical Trial Management System Good Clinical Practice Budget Management Contract Negotiation And Management Manage And Track Compliance Training Corrective Actions Standards Compliance Ctms Software Validation Software Documentation Validation Edc 21 Cfr Part 11 Protocol Clinical Data Management

Joann Pfeiffer, Drsc Education Details

Frequently Asked Questions about Joann Pfeiffer, Drsc

What company does Joann Pfeiffer, Drsc work for?

Joann Pfeiffer, Drsc works for Arizona State University

What is Joann Pfeiffer, Drsc's role at the current company?

Joann Pfeiffer, Drsc's current role is Healthcare Innovation Catalysts.

What is Joann Pfeiffer, Drsc's email address?

Joann Pfeiffer, Drsc's email address is dr****@****asu.edu

What is Joann Pfeiffer, Drsc's direct phone number?

Joann Pfeiffer, Drsc's direct phone number is +148096*****

What schools did Joann Pfeiffer, Drsc attend?

Joann Pfeiffer, Drsc attended University Of Southern California, University Of Southern California, University Of Utah, University Of Utah.

What are some of Joann Pfeiffer, Drsc's interests?

Joann Pfeiffer, Drsc has interest in Gardening, Outdoor Activities, Mentoring, Reading, Travel.

What skills is Joann Pfeiffer, Drsc known for?

Joann Pfeiffer, Drsc has skills like Clinical Trials, Regulatory Submissions, Ctms, Regulatory Affairs, Management, Clinical Research, Fda, Program Management, Project Management, Pharmaceutical Industry, Medical Devices, Quality Assurance.

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