michener INSTITUTE

Be a CRA

    

What are Clinical Trials?

Clinical trials are well controlled, scientific studies conducted on human subjects. These studies test the effects, risks and benefits of medicinal products, including new and currently marketed drugs and devices.

What does a Clinical Research Professional do?

The Clinical Research Team is made of a number of professionals, each with its own role and responsibility to contribute to the overall success of the clinical trial. Members of the team include the investigator, research coordinator, sponsor, clinical research associate (monitor), quality assurance associate, nurses, technicians and more. These team members assist in the design, preparation, planning, implementation, conduct and review of a clinical trial to ensure it adheres to regulatory and ethical standards.

Why become a Clinical Research Professional?

Clinical Research professionals contribute to research studies that in turn have a major impact on health care, such as developing new medications, and testing new treatment devices and methods. Significant advancements in these areas and expanding regulatory requirements have increased the demand for trained clinical research professionals.

Career Opportunities 

 Clinical research is a rapidly expanding field, creating exciting opportunities for trained professionals. Clinical research professionals work in a broad range of research settings, including:

• Academic health centres
• Government agencies and departments
• Contract research organizations
• Physician practices
• Private companies, such as pharmaceutical, biotechnology, and medical device firms

Graduates of this program would seek entry level employment in the hospital or the private health sector. These employment settings may provide the opportunity to advance to more senior roles with additional education and/or experience.

Graduates of this program who meet the minimum requirements may be eligible to write certification examinations through either ACRP or SoCRA.

course outline

What will I learn?

When you enroll in Michener’s Clinical Research Graduate Certificate program, you will acquire the technical expertise, knowledge and interpersonal skills needed to become a valuable member of a clinical research team.

• Ethical theory and ethical issues related to clinical research
• Phases and elements of clinical trials
• Good clinical practices
• Health Canada, ICH and Food and Drug Administration regulations and guidelines
• Challenges in the conduct of clinical trials
• Monitoring clinical trials

Required Courses:

Note: If you have already completed ICCR110, then you need only complete the 3 compulsory courses listed to complete the certificate. If you have not completed ICCR110, then you will complete an elective as your fourth course.

ETCR 120 Ethical Issues in Clinical Research

CRCR 130 Principles of Clinical Research I

CRCR 240 Principles of Clinical Research II

Elective Courses (Coming in 2014-2015):

MCCR140 Monitoring Clinical Trials

RMCR110 Research Methodology and Biostatistics

Admission Requirements

Admission requirements to the Graduate Certificate Program are:

• Bachelor of Science in a health sciences field or
• Registered Nurse or
• Registration in one of the regulated health professions or
• Certification with a recognized body in one of the health technologies [e.g. certification with CSMLS, CSRT or CAMRT] or
• Current employment in clinical research
• Computer literacy

Please Note: Applicants who do not meet the above requirements but who have current, relevant work experience in an appropriate research environment will be assessed on an individual basis. Submission of two letters of support will be required; one from a direct supervisor and one from your human resources department. A current resume describing your background and experience will also be required.

Students must have access to a computer that meets the minimum system requirements, access to the Internet and an e-mail account.

Students must meet Michener’s English language proficiency policy. Please view the English Language Proficiency Policy for further information. If you require an English language assessment, please review our English Language Assessment page for specific requirements.

How long does the program take?

Michener’s Clinical Research Graduate Certificate program is offered online. Study on your own time, and complete the program in twelve months if you enroll in one course per semester through four continuous semesters. Graduates receive The Michener Institute’s Clinical Research Graduate Certificate.

Start Date

Courses for the Clinical Research Program are completed through continuing education on a course by course basis. Online courses are offered several times throughout the year. Many students wish to take these courses for interest only. You may register for these courses without applying for the certificate.

If you would like to be granted a certificate in this program, qualified students must meet the admission requirements as posted, including any language requirements, and must apply to the program with full supporting documentation.This application can be made at any time, however please note that it will take one month for the Registrar’s Office to process the application. If you are seeking admission to the certificate program prior to registering for a course, please ensure you apply for the certificate one month before Registration closes for the course. Please keep in mind that some courses close before the registration date if their maximum capacity is met.