Clinical Research Management Certificate Program

Program Overview

The University of Michigan School of Nursing (UMSN) certificate program in Clinical Research Management prepares you for a rewarding career supporting potentially lifesaving research. Tomorrow’s leading research managers and coordinators can complete this 4-course online program taught by prestigious University of Michigan faculty in less than a year (or you can take single courses, if preferred). The program prepares its participants to assist investigators in developing and conducting clinical research studies, both investigator-initiated and industry-sponsored. The web-based program is designed to be convenient for professionals, recent college graduates and those with equivalent experience.
 
Space is limited, so register now to take Systems and Information Technology for Research (course #4), which will begin April 1, 2014:
 
Register Online - Click to Begin
 

What Makes this Program Unique?

Successful graduates of the University of Michigan School of Nursing Clinical Research Management Certificate program will be prepared to meet requirements for Society of Clinical Research Associates, Inc. (SOCRA) certification. The courses are designed to deliver key competencies necessary for both investigator-initiated and industry-sponsored research, including the following:
  • Understand and apply scientific principles of research to the implementation of both investigator-initiated and industry-sponsored clinical research
  • Apply ethical principles and meet regulatory requirements in the implementation of the clinical research protocol
  • Systematically implement the research protocol and maintain and evaluate the integrity of the research
  • Apply knowledge of data management, information management and scientific communication
  • Demonstrate professionalism and personal accountability in the implementation of research studies.
  • Apply management and leadership principles to support the research team
The University of Michigan has been #1 in research and development spending among the nation's public universities for three years in a row, according to U.S. National Science Foundation rankings. Research is fundamental at the University of Michigan School of Nursing, which ranked #6 in NIH funding among schools of nursing in 2012.
 
In addition to building upon such strong research experience, what distinguishes the UMSN Clinical Research Management program is that it educates participants on clinical principles that apply across all types of research and settings. Many existing programs just focus on coordinating industry-driven studies and the FDA work to bring drugs, biologics, and devices to market. U-M scientists have great expertise in clinical research, an area not currently well-served in programs nationwide and internationally. We leverage this expertise in preparing research coordinators for employment within academic settings, where knowledge develops in leaps and bounds, and in industry clinical settings. Industry is also innovating with new designs such as adaptive clinical trials, which will test the knowledge, efficiency, and expertise of research coordinators. The best-prepared research coordinators will be able to work in both industry and academic study settings, as this curriculum prepares them to do.
 
The program lead is Jan Larson, Ph.D., RN, FAAN. The lead faculty member (focused on curriculum) is Terry VandenBosch, Ph.D., RN, CIP, CCRP, who also works in the U-M Office of the Vice President for Research; she ensures alignment of the UMSN certificate program with the highest standards of conduct for research. Problems and ethical issues that arise in research studies often have to do with not understanding regulatory issues and protocols.
 

Background of Program

Clinical research is an increasingly complex endeavor. New challenges arise as technology enables new science and new types of collaboration, funding mechanisms change, and the need for interdisciplinary research teams continues to expand. The national emphasis on translational and “bench to bedside to population” research requires that clinical researchers expand their focus to address more rapid dissemination of research findings and innovation. Subsequently, a professional focused on managing the complexities of clinical research – from inception to dissemination, and fully informed on regulatory, compliance, and responsible conduct of research – is highly valued.  This curriculum was developed to enhance the number of trained coordinators.

Curriculum

The following courses are required to complete the program, and are initially offered in sequence as indicated below. Cost is $2,500 per course. Courses can be taken individually, with a certificate of completion available at the end of each course.
Course
Sequence
Course Title
Learning Objectives
Scheduled
Start Date
Course Contributors
Course 1
Foundations of Clinical Research
July 1, 2013

Jesus M. Casida, PhD, RN

  • Basic concepts and scientific principles of clinical research
  • Ethical and responsible conduct of clinical research
  • Accountability and professionalism in the implementation of research
Course 2
Regulatory Compliance and Clinical Study Operations
October 1, 2013Monica Orians, BS, MT(ASCP), CCRC
Jeanne Wright, RN, BSN, MT, CCRP, CIM, RAC, SoCRA
Terry VandenBosch, PhD, RN, CIP, CCRP
  • Analysis of roles and responsibilities of members of the clinical research team
  • Apply the requirements and standards of regulatory and accrediting bodies relevant to clinical research
  • Meet reporting requirements for investigator-initiated and industry-developed research
  • Address unique challenges associated with implementing research studies such as biorepositories, international studies, and genetic studies
Course 3
Implementation of the Research Protocol
January 6, 2014Eileen Robinson, MPH, BSN, RN-BC, CCRC
Terry VandenBosch, PhD, RN, CIP, CCRP
  • Strategies to maintain subject safety and data quality
  • Analysis of strategies for effective and responsible implementation of clinical research studies
  • Development of plans to evaluate the implementation of investigator-initiated and industry-developed studies
  • Comparison of challenges in conducting single-site and multisite studies
Course 4Systems and Information Technology for Research
April 1, 2014Marcelline Harris, PhD, RN
  • Describe basic concepts for computing and technology including hardware, software, databases, programming, networks and security
  • Explain factors that inform the design and development of systems that facilitate clinical research
  • Summarize the influence of advanced technologies on future directions in the conduct and dissemination of clinical research
  • Examine the management and leadership knowledge and skills required to support clinical research
 

Our Student Population Base - Local to Global Reach

  • Locally:  Approximately 2,000 research coordinators already working on University of Michigan projects can benefit from research management certification to strengthen knowledge and skills and establish professional identity. The recent, rapid growth of the U-M North Campus Research Complex (now numbering more than 2,000 occupants) provides an ever-increasing pool of professionals seeking expertise in this field.
  • Regionally:  The Michigan Research Corridor that includes the University of Michigan, Wayne State University, and Michigan State University is rapidly expanding and creating a great regional need for professional training in this field.
  • Nationally:  All research-intensive academic settings and institutions that conduct health research need training programs. Nurses and other professionals considering changing careers or updating their skills can apply their professional, organizational and problem-solving skills to the dynamic and growing field of research coordination.
  • Globally:  U-M has global health partnerships in China, Africa, South America, and Europe. They must meet U.S. regulatory requirements for a growing number of industry-sponsored studies.

Frequently asked questions (FAQs)

    1. Why should I take these courses?
      The UMSN Clinical Research Management certificate program provides a unique blended approach to both investigator-initiated and industry-sponsored studies. You'll be taught by prestigious University of Michigan faculty, drawing from experience conducting both kinds of research trials. No travel is required for this web-based program, so you can do the coursework where and when you want provided you have an internet connection available to you.

    2. How will this certificate program help me to get a better job?
      Research is at the core of progress in promoting health worldwide, and complexity continues to increase in the regulatory environment, study designs, recruitment of participants, and coordination of multiple studies (adaptive clinical trials, bench to bedside, etc.). The best-trained clinical study managers, competent in all the areas taught in this certificate program, will get the best jobs.

    3. What is the weekly time commitment for each course?
      This will vary by course and student. It is recommended that students plan for at least an average of five hours per week to successfully complete the courses. The courses will involve readings, activities to gain skills and understand material, occasional assignments to reinforce course content and a short assessment that material has been learned.

    4. Are there technical requirements for doing the coursework?
      Course content will be delivered using a combination of media formats including video and PDF files. Participants in the program will need to have a computer with Internet access and bandwidth sufficient to download and play video clips. Required software includes a standard browser: Internet Explorer (version 8 or higher strongly recommended if using IE), Chrome, Safari or Firefox; a media player: VLC or Windows Media Player; Adobe Reader, and a document editing tool: Open Office or MS Office.

    5. What is the registration process?
      The registration process is quick and easy. Simply click on the blue "Register Online" button above and fill out the registration information. College graduates will be asked to send an official transcript of highest degree earned. A School of Nursing representative will contact all applicants, confirm the chosen payment method and answer any submission questions you may have.

    6. Where should I send my transcript?
      College graduates are asked to send a copy of the transcript of highest degree earned directly to the School of Nursing at the following address:
           School of Nursing
           Attn: Clinical Research Management Certificate Program
           400 N. Ingalls, Suite 1160
           Ann Arbor, MI 4819-5482  

    7. How can I pay for course(s) fees?
      You are encouraged to download and print: Guide to Fee Payment Options for complete details on the various methods through which payment can be made for course fees. 

    8. Do I have to pay all at once if I am registering for all four courses?
      The payment schedule is flexible for students choosing to take more than one course. You may submit the entire payment upon registration or individually for each registered course prior to the course start date.

    9. Are students required to take all four courses?
      No, students may choose any of the courses, take them independent of the others, and earn a certificate of completion available at the end of each course.

    10. How long will it take to complete the full program?
      If students take all four courses the first time each course is offered, students can earn their full Clinical Research Management certificate in less than one year.

Please contact the School of Nursing - Office of Student, Academic & Multicultural Services (OSAMS) for any additional questions you may have:

Via phone: (734) 763-5985 (Monday - Friday, 8 a.m. - 5 p.m., Eastern time)