Fundamentals of Clinical Research
Earn an affordable postgraduate certificate and get job-ready for an in-demand career. Learn how to lead clinical research studies from start to finish. No prior experience necessary to get started.
In this advanced postgraduate credential program, you will learn how to develop both the general and specialized skillsets needed to build successful careers in a variety of clinical trials management and research sectors. You’ll learn fundamentals of clinical trials, concepts, regulations, protocol development, quality and compliance, good practices and techniques required to work in the clinical research field. You will gain knowledge and skills in the planning and management of clinical research including practices related to organization, execution, and monitoring of clinical trials.
Program Format and Length
This certificate program is a self-paced study, delivered online so you study in the comfort of your own home any time and can enroll from anywhere in the world. The program length is 6 months, the duration however will depend on the individual participant and their prior knowledge of the subject matter. On average the course will take 3 months to complete if 8-10 hours of effort is dedicated each week.
This program is available to domestic and international students.
In this online Postgraduate credential program, you’ll interact with our world-class faculty. Your learning experience will also feature a range of assessments, including quizzes, and reflective exercises.
Who is this Clinical Research Certificate for?
⦁ New Graduates holding a degree in life science who want to pursue this in high demand career though joining Pharmaceutical Companies, Contract Research Organizations (CROs), Hospitals, Government Agencies, and Academic Centers.
⦁ Internationally Educated Medical Doctors, Dentists, Veterinarians, Pharmacists who wish to meaningfully apply their existing skills and experience.
⦁ Trained Nurses (RNs), Nurse Practitioners and Physician Assistants seeking for professional growth and advancement.
⦁ Lab Technicians and Medical Technologists who are looking to move into a related career.
⦁ Individuals currently working in clinical research who want to refresh their knowledge and familiarize themselves with up-to-date FDA and Health Canada regulations.
⦁ Students in the final year of life science programs and want to get job-ready for the clinical research career. Students will have 12-month access to the course.
Grading and Final Results
At the end of most of the modules, there is a non-graded quizzes for the purpose of testing and retaining your knowledge. After finishing all modules, the final exam will be assigned to the student, the exam consists of a 120 multiple choice question. To pass the exam, one must get a score of at least 70%. Participants do not achieve 70% can review the modules content and try again after 2 weeks for free. Exam Questions are randomly selected from approximately 1000 question bank, making each exam unique.
Timeline for quizzes
Once exam is assigned, it will have a 24–48-hour window, within which the student can start taking it. Once started, the student will have to finish within a stipulated time as specified in the exam (2 hours).
If at any point of time CACRS found out that information provided by a candidate for establishing his/her eligibility was not authentic, he/she will be disqualified. Any Certificate provided to a disqualified student will stand revoked. Submitting answers of the final exam that are not a student’s own may result in permanent failure in the course. Such a behavior will be highlighted to employers/recruiters during verification process.
Award of Certificate
A student passing the final exam is given the Post Graduate Certificate in Clinical Research sealed by the stamp of CACRS. The certificate has no expiry date.
Change of Rules
CACRS reserves the right to make changes in the above rules, program structure, and the curriculum as and when needed. The modified rules will be applicable prospectively to students joining the program after the rules are modified.
Upon graduating from this program, you will be prepared to pursue a range of jobs with pharmaceutical and biotech companies, Contract Research Organizations (CROs), Hospitals, and Academic Institutes such as:
⦁ Clinical Research Specialist
⦁ Clinical Research Associate/Monitor
⦁ Clinical Research Nurse
⦁ Clinical Research Coordinator
⦁ Clinical Research Assistant
⦁ Data Entry Coordinator
⦁ Clinical Research Team Lead
⦁ Clinical Research Manager
⦁ Clinical Research Project Manager
⦁ Clinical Research Scientist
Upon Successful completion of the program, a graduate will be able to:
⦁ Perform the duties of a clinical research professional, as part of a project team, at all phases of the clinical trial.
⦁ Maintain ethical and regulatory standards to ensure the protection and safety of clinical trial participants and the integrity of research data.
⦁ Demonstrate an understanding of FDA and Health Canada
⦁ requirements for clinical trials.
⦁ Demonstrate accuracy and reliability in data collection, management, and analysis.
⦁ Understand the stages in setting up clinical trials.
⦁ Identify the roles and responsibilities of the different positions (Principal Investigator, Clinical Research Specialist/Associate, Clinical Research Coordinator, Study Participant) within the clinical research process.
⦁ Evaluate, recognize, and respond to project-related challenges to proactively resolve issues, mitigate risks, and improve quality of projects.
⦁ Construct clinical research protocol.
⦁ Examine ethical issues in clinical research and select appropriate strategies.
⦁ Plan, manage and monitor clinical research and trials.
⦁ Demonstrate an awareness of ethical practices and professional standards applicable for clinical research.
⦁ Effectively communicate with the various stakeholder groups engaged in clinical trials.
⦁ Analyze clinical research processes and products from multiple perspectives to identify potential impacts on industry.
⦁ Create a clinical development plan for a novel therapeutic product.
⦁ Evaluate clinical research practices according to recognized Quality Assurance Process.
⦁ Adhere to the principles and practices of specific Standard Operating Procedures to prepare and manage documentation and data in compliance with approved protocols.
⦁ Collaborate with study participants, research teams, and regulatory and business professionals to contribute to high quality clinical research processes.
⦁ Contribute to high quality clinical research processes through collaboration with research team, study participants, regulatory and business professionals.
CR001 Introduction to Clinical Research and Drug Development (5 Modules)
CR002 Principles of Clinical Research (5 Modules)
CR003 Good Clinical Practice (GCP) and Ethics (6 Modules)
CR004 Regulatory and Ethical Issues in Clinical Trials (5 Modules)
CR005 Organization and Clinical Trials Monitoring (5 Modules)
CR006 Clinical Trial Design (5 Modules)
We strive to develop work ready learners upon graduation through a collaborative partnership between students and program. It is our mission to offer our learners the means to excel in the field of clinical research, as Clinical Research Specialist/Associate or Clinical Research Coordinator, by providing industry relevant professional, theoretical, and hands on experience.
Program Fees for members: $279
Program Fees for non-members: $1400
Fees are in Canadian Dollars. Due to the current economic crisis, the fee of the program is substantially subsidized and reduced for members to become affordable and are subject to change.