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.
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.
This quiz is to test your knowledge of the main concepts taught in the lesson 1
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.
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.
This quiz is to test your knowledge of the main concepts taught in the lecture 3.
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.
This quiz has 5 questions. Please complete the quiz before going to the next lecture.
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.
You have 5 questions for this lecture. Please read the resource materials to understand further regulatory requirements
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
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.
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.
You have 2 questions, please refer to all the resources to answer the questions.
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.
This quiz has 2 questions. Please refer to additional resources if needed.
This quiz has only 2 questions. Please refer to all the materials provided.
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.
This quiz has only 2 questions, please refer to all materials provided.
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),