Textbooks_2022
a:2:{s:7:"content";s:101343:"
| Book Title | Author(s) | Year | Publisher | Course(s) |
| Project Management (8th edition) | Larson, E.W. & Gray, C. F. | 2019 | McGraw-Hill | Project Management, Leadership |
| An Overview of FDA Regulated Products | Pacifici, E. & Bain, S. | 2018 | Academic Press | Regulatory, Regulations, |
| Fundamentals of International Regulatory Affairs, 4th Ed | 2018 | RAPS | International Regulatory Affairs and Regulations | |
| Clinical Research Management Complementary Materials | Shah, K.& Pfeiffer, J. | 2021 | LAD Custom Publishers | Conduct of Clinical Research Budgets Contracts Monitoring Clinical Research Operations Research Methods Quality in Research |
| A Practical Guide to Managing Clinical Trials | Pfeiffer, J. & Wells, C. | 2017 | CRC Press/Taylor & Frances | Clinical Trial Operations Managing Clinical Trials |
| CRA's Guide to Monitoring Clinical Research (4th Ed) | Weeks-Rowe, E., Woodin, K. & Schneider, J. | 2016 | CenterWatch | Managing Clinical Trials Monitoring Clinical Trials Study & Site Management |
| Managing Clinical Trial Budgets & Contracts | Pfeiffer, J. & Winschiegl | 2016 | LAD Custom Publishers | Contracts Budgets Budgets & Contracts |
| Business Administration for Clinical Trials: Managing Research Strategy, finance, regulation and quality | Cavilieri, R.J. & Rupp, M.E. | 2015 | Sigma Theta Tau | Study and Site Management |
| FDA Regulatory Affairs | Pisano, D.J. & Mantus, D. (eds) | 2014 | CRC Press/Taylor & Frances | Regulatory Affairs Fundamentals of New Product Development |
| Healthcare Project Management | Macrina, F.L. | 2014 | ASM Press | Clinical Research Ethics and Leadership |
| Medical Device Development: Regulation & Law | Kahan, J. | 2014 | Parexel | Medical Device Regulations |
| Translational medicine and drug discovery | Littman, B. & Krishna, R. | 2014 | Cambridge University Press | Translational Research |
| Clinical Research Manual: Practical tools and template for managing clinical research | Cavilieri, R.J. & Rupp, M.E. | 2013 | Sigma Theta Tau | Study and Site Management |
| Healthcare Project Management | Schwalbe, K. & Furlong, D. | 2013 | Schwalbe Publishing | Project Management |
| Introduction to healthcare quality management (2nd Ed) | Spath, P.L. | 2013 | Health Administration Press | Quality |
| Transcelerate Training Modules for Risk-Based Monitoring | www.transceleratebiopharmainc.com | 2013 | Quality Monitoring | |
| A Pracitcal Guide to Data Management, 3rd Ed | Prokscha, S. | 2012 | Taylor & Frances | Data Management |
| Clinical Research and the Law | Tereskerz, P.M. | 2012 | Wiley-Blackwell | Regulatory Affairs |
| Principles and practice of clinical research (3rd Ed) | Gallin, J.I. & Ognibene, F.P. (eds) | 2012 | Elsevier | Fundamentals of New Product Development |
| Practical Guide to Clinical Date Management (3rd Ed) | Prokscha, S. | 2011 | Taylor & Frances | Data Management |
| The Oxford Textbook of Clinical Research Ethics | Emanuel & Christine C. Grady | 2011 | Oxford University Press | Research Ethics |
| A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim (2nd Ed) | Liu, M.B. & Davis, K. | 2010 | Wiley-Blackwell | Intro to Clinical Research |
| Fundamentals of Clinical Trials, 4th Ed. | Friedman, L.M., Furber, C. D. & DeMets, D | 2010 | Springer Publisher | Study Development Ethics |
| Strengths Based Leadership: Great Leaders, Teams, and Why People Follow | Rath, T. & Conchie, B. | 2009 | Gallup Press | Clinical Research Ethics and Leadership |
| Targeted Regulatory Writing Techniques: Clinical Documents for Drugs & Biologics | Wood, L.F. & Foote, M. | 2009 | Springer Publisher | Regulatory Writing Fundamental of New Product Development |
| New Drug Development: A Regulatory Overview, 8th ed | Mathieu, M. | 2008 | Parexel | Drug Development and Regulations |
| Evaluating the Science and Ethics of Research on Humans: A guide for IRB Members | Mazur, D.J. | 2007 | IRBs and Research Scientific and Research Review Boards | |
| Introduction to the Responsible Conduct of Research | Steneck, N. | 2007 | http://ori.hhs.gov/education/products/RCRintro/ | Conduct of Clinical Research |
| Practical Guides to Quality Management in Clinical Trial Research | Ogg, G. | 2006 | Quality in Research Quality in Clinical Trials | |
| Crucial Conversation: Tools for Talking When Stakes Are High | Patterson, K. | 2002 | McGraw-Hill | Clinical Research Ethics and Leadership |
| Integrity in Research: Creating an Environment that Promotes the Responsible Conduct of Research | Committee on Assessing Integrity in Research Environments, National Research Council, Institute of Medicine | 2002 | Conduct of Clinical Research | |
| The Five Dysfunctions of a Team: A Leadership Fable | Lencioni, P. | 2002 | Jossey-Bass | Clinical Research Ethics and Leadership |
| Designing Clinical Research (4th Ed) | Hulley, S., Cummings, S., Browner, W., Grady, D. & Newman, T. | 2001 | Lippincott, Williams & Wilkins | Research Methods & Desing |
| Medical Device Development: A Regulatory Overview | Kahan, J. | 2000 | Parexel | Medical Devices |
| Project Management - The Managerial Process | Larson, E.W. & Gray, C. F. | McGraw-Hill | Project Management | |
| Safety and Evaluation in the Development of Medical Devices and Combination Products (3rd Ed) | Gad, C. & McCord, M.G. | CRC Press/Taylor & Frances | Medical Devices | |
| The Research Methods Knowledge Base (3rd Ed) | Trochim, W. & Donnelly, J. | Atomic Dog | Study Development Ethics | |
| Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators (2nd ed.). | Stone, J. | 2010 | Mountainside MD Press | Intro to Clinical Research |
| Principles of Biochemistry, 8th Edition | Nelson, D., Cox, M. | 2015 | W.H. Freeman & Company | Biochemistry |
| Fundamental Laboratory Approaches for Biochemistry and Biotechnology, 2nd Edition | Ninfa, A.J., Ballou, D.P, & Benore, M. | 2010 | John Wiley & Sons | Biochemistry Lab |
| Introductory Statistics, 8th Edition | Mann, P.S. | 2018 | Wiley Publishing | Introduction to Biostatistics |
| Clinical Pharmacology Made Ridiculously Simple, 5th Edition | Olson, J. | 2015 | MedMaster Inc | Introduction to Pharmacology |
| Basic and Clinical Pharmacology, 14th Edition | Katzung, B. |