Humber’s Clinical Research graduate certificate program focuses on developing the concepts, skills 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 the organization, execution and monitoring of clinical trials. You will learn clinical trial protocol development as part of the principles and processes of clinical trial design.
There is a focus on maintaining good clinical practice (GCP), as presented by the International Conference on Harmonization (ICH), and the importance of data collection, analysis, recording, and auditing, for ensuring that clinical trial data are credible and accurate. You will become familiar with the many regulations and guidelines established to ensure trials are conducted ethically and in a way that respects the rights of clinical trial participants, while also ensuring that robust scientific research is done.
Teamwork and communication skills are emphasized throughout the program and you will acquire the necessary technological skills to assist with data management specific to the field.
Upon successful completion of the program, a graduate will:
• Perform the duties of a clinical research professional, as part of a project team, at all phases of the product/treatment development and post-market processes.
• Consider political, social, and economic factors when making decisions related to clinical research practices in order to plan responses for potentially challenging and complex outcomes.
• Analyze clinical research processes and products from multiple perspectives to identify potential impacts on industry.
• Synthesize scientific, regulatory, and business information from various sources to prepare effective clinical research documents.
• Maintain ethical, legal, regulatory, and professional standards associated with clinical research.
• Create a clinical development plan for a novel therapeutic product.
• Evaluate clinical research practices according to recognized Quality Assurance Process.
• Integrate effective technology and record-keeping practices within all stages of clinical research and post marketing processes to ensure compliance with research approvals and professional and ethical standards of practice.
• Adhere to the principles and practices of specific Standard Operating Procedures to prepare and manage documentation and data in compliance with approved protocols.
• Prepare and critique submissions for clinical trials and marketing approvals that meet regulatory and industry requirements.
• Apply critical analysis, problem solving, and project management skills to recognize and respond to complex clinical research challenges.
• Engage in knowledge translation to contribute to the advancement of the health care industry.
• Collaborate with study participants, research teams, and regulatory and business professionals to contribute to high quality clinical research processes.
• CLRE 5000: Introduction to Clinical Research
• CLRE 5001: ICH and Legislation Governing Clinical Research
• CLRE 5002: Communications
• CLRE 5003: Clinical Laboratory Procedures and Diagnostic Testing
• CLRE 5004: Pharmacology
• CLRE 5005: Physiology with Pathophysiology
• CLRE 5500: Non-Drug Medical Products
• CLRE 5501: Organization and Monitoring of Clinicals Trials
• CLRE 5502: Data Management and Biostatistics
• CLRE 5503: Seminars in Clinical Research
• CLRE 5504: Clinical Project Management
• CLRE 5505: Clinical Documentation
• CLRE 5600: Internship
• CLRE 5610: Integrative Seminar
Following two online academic semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies and hospitals.
How to apply
Click here to apply: http://humber.ca/admissions/how-apply.html
For information on funding, please use the following link: http://humber.ca/admissions/financial-aid.html