Foundations of Clinical Research Management
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Full program description
What you'll learn:
The Foundations of Clinical Research Management Program provides a basic introduction and foundation for the management of clinical studies. It consists of three courses which include Introduction to Ethics in Research, Introduction to FDA Regulations for Human Subject Research, and Introduction to Clinical Research Operations.
What you'll do:
- Introduction to Ethics in Research
This course provides a basic foundation in clinical research ethics and presents challenging ethical questions for individuals related to appropriate use, access, safety, and rights and obligations. The course introduces informed consent, vulnerable populations, confidentiality, harm and benefits, justice, society, and emerging technologies.
- Introduction to FDA Regulations for Human Subject Research
This course provides an overview of the history, framework and FDA regulations that govern the conduct of clinical research in the US. The course includes a review of regulations related to the conduct of clinical trials, protection of research subjects, good clinical practices, roles and responsibilities of study staff, sponsor, IRBs, and ends with a look at global regulatory authorities.
- Introduction to Clinical Research Operations
This course focuses on providing a basic understanding of clinical research operations. The course includes a broader introduction to human subject research, the medical product development processes, and the types and designs of clinical research studies. The course provides an insight into planning an execution of clinical studies, including processes, documentation, and stakeholders. The course explores the international scenario of clinical research operations.
Who this course is designed for:
Courses are designed for:
- Individuals who may be new to the profession and want a strong foundation in clinical research
- Those who would like a refresher
- To be used as a bridge for those who are interested in the Clinical Research Management Program at ASU but do not have the required 6 months employment experience
- For those exploring a career in clinical research
- and as continuing education
What you'll receive:
A certificate of completion
Meet the instructors
JoAnn Pfeiffer, DrSC, MS, RAC, CCRA - Senior Director and Clinical Professor
Dr. Pfeiffer is the Senior Director and a Clinical Professor for the Masters’ Degree programs in Clinical Research Management (CRM) and Regulatory Science (RS) at Arizona State University (ASU). She has been with ASU since 2014, starting as a faculty associate, moving to the position of Associate Director in 2015 and Program Director in 2016 Program Director and is currently the Senior Director. During her tenure she has had the opportunity to be involved in the growth, success and many wonderful opportunities provided in academia. She was instrumental in adding the Regulatory Science Masters online program, the Regulatory Science Masters hybrid program, and recently a certificate and concentration in Food Safety in the Regulatory Science Program. She has watched the program grow and graduates become leaders in the medical products field. She coordinated the application for program accreditation for the CRM programs in 2018 and ASU became the first accredited program in the US.
Kaushal Shah, PhD - Clinical Associate Professor
Dr. Shah is a Clinical Research Professional with an extensive and diverse experience in the Clinical Research domain. Kaushal holds a Ph.D. in Biochemistry. She is a member of the Association of the Clinical Research Professionals (ACRP), a member of the Society of Clinical Research Associates (SOCRA) and also a member of the Association of Global Regulatory Educators (AGRE).
Dr. Shah has worked in both, the industry and in academic positions. Her major areas of work include clinical research management, operations, financial planning and regulatory compliance. Kaushal has worked with a large spectrum of products (pharmaceutical drugs, biological drugs, diagnostic products and stem cells) and with public and private health care facilities globally.
Barbara Marusiak, DHsc - Instructor
Dr. Barbara Marusiak is a seasoned research and healthcare professional. She has over 35 years of experience in Medical Devices, Clinical Data Management, eCRF, Clinical Research Experience, and Biotechnology. Recently as Senior Clinical Trials Operations Manager, she oversaw the development, implementation, and administration of industry-sponsored domestic and international clinical trials. She ensured compliance with sponsor requirements and provided professional guidance and leadership to ensure processes, procedures, and activities are in compliance with industry standards, Good Clinical Practices, and additional current state, federal, and international regulations and guidance in human subject research. Her expertise includes clinical process development, clinical cycle time, and process improvements.
Dr. Marusiak acquired her operational and governance experience in the following settings: the United States Air Force; rural, academic, and urban hospitals; medical device and biotech companies; and clinical research organizations.
Dr. Marusiak is a strong education professional holding a Doctorate of Science in Global Health (DHsc), Master’s in Clinical Research Management (MS CRM), and a Bachelor’s in Nursing (BSN). She is a member of the Society of Research Professionals (SOCRA), Association of Clinical Research Professionals (ACRP), and Society for Clinical Trials. Currently serves on the editorial board of the International Journal of Nursing & Clinical Practices.
Frequently Asked Questions:
Who is eligible to take these courses?
These courses are available to anyone who is interested in clinical research management. They are ideal for:
- Individuals new to the profession and want a strong foundation in clinical research.
- Professionals who would like a refresher course or for continuing education.
- Applicants to the Clinical Research Management (CRM) Program at ASU who do not have the required 6 months’ work experience - you can use the courses as a bridging Program.
- Those who are exploring a career in clinical research.
Do I need any work experience to take these course?
Do I need a bachelor's degree to take these course?
No. However, if you are applying to the Clinical Research Management Master's Program, you must have completed a bachelor's degree.
How much time does it take to complete the courses?
The Program has three courses. Each course consists of 9 modules and requires about 45 hours of seat time. The courses are self-paced. Some students finish a course in as little as 1 – 2 weeks. Most individuals can easily complete each course within a month.
Should I take all three courses together?
You can take any of these courses individually. If you are interested in only one of the three areas in the program, you may sign up just for that course.
If you choose to register for all three courses as a bundle you receive a 25% discount.
Applicants who apply to the Clinical Research Master’s Program and use these as a replacement for the 6 months experience receive a 33% discount. Your application must have been completed, reviewed by the admission committee and you have received conditional acceptance to the Master’s Degree based on completing and passing the three courses.
What if I have questions about an assignment or quiz?
Courses are independent study and self-paced. We provide a faculty coordinator to answer questions you may have about the courses and the assignments.
Will I receive academic credits for these courses?
These courses are not for credit and cannot be applied to academic programs.
What will I receive upon completion of a course?
If you successfully complete a course (minimum score of 80%) you will receive a certificate of participation, stating you successfully completed the course.
How will I know if I successfully completed a course?
Each course includes a quiz at the end of each module and a quiz covering the full course material at the end of the course. You will receive your score after completing each quiz. If you did not pass a quiz or would like to improve your score you are allowed to take each quiz twice.