Clinical Research for Beginners

The Essentials of Clinical Trials
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  • Lectures 11
  • Contents Video: 1.5 hours
  • Skill Level Beginner Level
  • Languages English
  • Includes Lifetime access
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    Available on iOS and Android
    Certificate of Completion
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About This Course

Published 4/2015 English

Course Description

Have you ever wondered what it takes to land a job in clinical research? First, you have to know what clinical research is all about and the potential jobs, and this course will give you that.

This course will provide you with the essentials of clinical research in a very summarized and concise manner to understand the process and to work towards building your qualifications for a job. You will learn about Good Clinical Practices and how it influences country specific regulations, the drug development process and the phases of clinical research and post-marketing research, which are the parties responsible in clinical trials, and what are the qualifications, background, training and experience a clinical research professional needs to have. This course is also supplemented with a complete description of the most typical jobs in clinical research and the not so typical, nevertheless very important.

This course is part of a series of eLearning by EduPharma and Global Research Pharma Canada, and provides credits towards the Certificate in Clinical Research and the Mater Certificate in Clinical Research and Drug Development.

What are the requirements?

  • Ideally, students should have a minimum 4 years post secondary education in medicine, pharmacy, science or allied discipline

What am I going to get from this course?

  • Understand the clinical research process
  • Learn about Good Clinical Practices
  • Identify and differentiate the different phases in clinical research
  • Comprehend about all responsible parties in clinical research
  • Determine if a career in clinical research could be suitable for the student
  • From the clinical research jobs described, choose the most appealing to you

What is the target audience?

  • The course Clinical Research for Beginners is ideal for recent graduates as well as experienced professionals in science, medicine and allied discipline who are looking into career in clinical research
  • Graduates from other areas are encouraged to attend this course to be able to understand which supplementary education is needed to enter into the exciting world of clinical research and development

What you get with this course?

Not for you? No problem.
30 day money back guarantee.

Forever yours.
Lifetime access.

Learn on the go.
Desktop, iOS and Android.

Get rewarded.
Certificate of completion.

Curriculum

Section 1: The basics of clinical research
10:42

The lecture number one introduces you in a very concise and easy to understand manner to clinical research. Each slide brings you closer to the essence of clinical research and drug development. Once you complete this lesson, you will have learned what clinical research is, as well as what is not, the main objectives of clinical research and the significance of the clinical trial results.

6 questions

This quiz is to test your knowledge of the main concepts taught in the lesson 1

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09:41

The lecture number two will introduce you to what is Good Clinical Practices as the core international guideline for clinical research. Once you complete this lecture, you will have learned what is GCP, as well as what does it mean to be GCP compliant, which parties have to be compliant to GCP, and how GCP affects country specific regulations.

What is GCP?
4 questions
Section 2: The Clinical Trial Process
09:45

This lecture will take you from discovery to marketing of a therapeutic product. You will understand pre-clinical and clinical development as well as post-marketing research. Here you will become familiar with the phases of clinical development as well as the main endpoints, subject population and treatments.

5 questions

This quiz is to test your knowledge of the main concepts taught in the lecture 3.

08:21

This lecture focuses in providing you with the main documents in clinical trials, explaining them precisely as well as its applications. Once you complete this lecture, you will have learned about the protocol, investigators brochure and patient information and consent forms, and you will be able to identify them in the context of a clinical investigation.


5 questions

This quiz has 5 questions. Please complete the quiz before going to the next lecture.

11:10

Clinical research is a highly regulated activity. In this lecture you will get the insight of regulatory requirements, focusing on the main markets (US and the EU). All the regulations are briefly discussed in function of GCP. At the end of this lecture you will be able to understand country specific regulations in the context of clinical trials.

5 questions

You have 5 questions for this lecture. Please read the resource materials to understand further regulatory requirements

05:56

This is the most important lecture for the novice: what do you need to know to work in clinical research.

This lecture will give you the necessary knowledge of which background, education, training and experience you need to have to qualify for a job in clinical research. At the end of this lecture you will be able to assess your qualifications for a clinical research job as well as the qualification requirements on jobs posted. Further you will be able to determine whether you need more training or education and which experience is necessary

What do you need to know to work in Clinical Research?
6 questions
11:03

The last lecture is dedicated to explain in detail the most common jobs in clinical research. Each and every position is discussed individually. Also, less common jobs are discussed to give you a wider view on this exciting career of clinical research and drug development. At the end of this lecture you will be able to indentify the jobs in the market as well as your eligibility.

05:23

This lecture focuses on a detailed analysis of the discovery process as well as other sources of new drugs for development. When you complete this lecture, you to have a complete idea of the drug discovery process.

2 questions

You have 2 questions, please refer to all the resources to answer the questions.

04:15

This lecture focuses on a detailed analysis of the pre-clinical development process. When you complete this lecture, you will be able to understand pre-clinical development and its objectives.

2 questions

This quiz has 2 questions. Please refer to additional resources if needed.

The Clinical Trial Process, Clinical Development
07:37
2 questions

This quiz has only 2 questions. Please refer to all the materials provided.

04:01

This lecture focuses on a detailed analysis of the post marketing development process. When you complete this lecture, you will be able to understand the post marketing development and its objectives.

2 questions

This quiz has only 2 questions, please refer to all materials provided.

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Instructor Biography

Dr. Vera Madzarevic, Director of R&D, Global Research Pharma Canada & CRIAMERICA

Dr. Madzarevic has more than twenty five years of experience in global pharmaceutical research, development and academic research. Trained as a medical scientist, she has held academic and industry positions internationally. Her areas of expertise include discovery, pre-clinical, clinical and post-marketing development. Vera has worked for world renowned pharmaceutical companies such as Ciba-Geigy in Canada and globally, as well as Novartis in East Hannover in the US as a Senior Scientist. Dr. Madzarevic completed her post-doctoral research fellowship at the Banting and Best Institute for Medical Research at the University of Toronto.

Her vast experience includes providing consultancy services for most major pharmaceutical and biotech companies across the globe. Vera´s particular expertise is centered on internal and pre-regulatory GCP, GLP, and CLIA pre-certification inspections, clinical trial management, drug development programs, quality assurance, and professional training. She currently heads the following companies: Global Research Pharma Canada, EduPharma Canada and the Clinical Research Institute of America . Vera was also the main coordinator of the Clinical Research Diploma Program (post graduate program in clinical research) at the Academy of Applied Pharmaceutical Sciences in Toronto, Canada. Vera is a published author, with her last work being Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections by Vera Mihajlovic-Madzarevic (Wiley, 2010),

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