Education / Teaching

Textbooks_2022

Oct 7, 2022 by JoAnn Pfeiffer

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.

Textbook List

Jul 29, 2021 by Jared Kerr

 Draft embedded Google Doc table.

Survey for Institutional Members and Students

Aug 15, 2018 by JoAnn Pfeiffer

Research: Competency Index for Clinical Research Professionals (CICRP): Measuring Competencies of CoAPCR Students

Letter to CoACPR Institutional Members

Good day. There is a team of CoAPCR institutional members who have developed a survey to measure the acquisition of competence and evaluate readiness of students or graduates of academic programs teaching clinical research from our various member institutions. The research study is entitled, "Competency Index for Clinical Research Professionals (CICRP): Measuring Competencies of CoAPCR Students".  Jared Kerr, Assistant Professor at the University of North Carolina-Wilmington (UNCW), is serving as the study's Principal Investigator. This research study was approved by the UNCW Institutional Review Board #18-0003. Jared Kerr has been granted access to the CoAPCR institutional member email distribution list. Jared Kerr will use CoAPCR email distribution list to provide each institutional member the survey recruitment materials. The recruitment materials include an email, paper flyer, and web message. The survey is anonymous and personal identifiers of students are not collected in the survey.

We would like CoAPCR institutional members to distribute information about the study using the approved survey recruitment materials to the qualifying student population at your respective institutions. Participation by you and any students is voluntary. Potential study participants will qualify for the study if they are current students or a graduate of an academic program teaching clinical research. You should distribute the survey recruitment materials using your institution's appropriate email distribution list, bulletin board, website, or social media site.

If you do participate in distributing the survey recruitment materials to your students, please let Jared Kerr know the total number of students who qualify to receive the recruitment materials. We need to know when survey recruitment messages are sent to your students and the number of potential survey participants. The number of undeliverable recruitment messages (e.g., email) will be counted, so the total potential number of survey participants is accurate.

Any questions regarding the study or survey including any questions from potential student participants should be directed to Jared Kerr.

Open Survey of CoAPCR Institutional Members

Sincerely,

Principal Investigator:
Jared Kerr, JD, MPH
College of Health and Human Services, University of North Carolina Wilmington

Study Co-Chairs:
Carolynn Jones, DNP, MSPH, RN
Carlton Hornung, PhD, MPH
Consortium of Academic Programs in Clinical Research (CoAPCR)

Survey Invitation to Students of Academic Programs in Clinical Research

Students or graduates of academic program teaching clinical research, please take a few minutes to complete an anonymous survey. This research study was approved by the UNCW Institutional Review Board #18-0003. Researchers need your help to measure the utility of a new competency index called the Competency Index for Clinical Research Professionals (CICRP). The CICRP aims to estimate perceptions of confidence and readiness in clinical research competencies.

Open Survey of Students

CTSA Program Good Clinical Practice Standards

Feb 23, 2017 by JoAnn Pfeiffer

Teaching Presentation by Carolynn Jones

Oct 15, 2014 by JoAnn Pfeiffer

  teachingpresentation-by-cjones.pdf