Clinical Research Associate / Coordinator (CRAT)

Clinical Protocol and Drug Safety Guidelines (CPDS)

3 Students Enrolled

This Program is designed by industry experts for students and young professionals looking for Entry and career advancement with pharmaceutical drug safety operations. This program provides in depth understanding of Clinical Protocol and Pharmacovigilance Regulatory practices and Guidelines followed by Pharmaceuticals for Drug safety and Pharmacovigilance Reporting and monitoring process.

Our Programs are delivered in SIP model for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.

Category: Drug Safety Price: $850.88 (CAD) Duration: 15 Days Language: English
Admission Requirements:

Recommended: An Associate or bachelor’s degree in Medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.

Application:

Please Email your resume to Human Resources qpdc@qtech-solutions.ca to check on your eligibility. We will contact you. Qtech's objective is to provide you the right career pathway and advancement required to meet your career goals.At the end of the program, the student takes a final exam to get certified. Qualified candidates will have the opportunity to avail of our Post Training Assistance (PTA Program) for getting prepared and finding jobs.

Learning Outcomes:
  1. We adapt guidelines followed by American-FDA (US Food and Drug Administration), European-EMA (European Medicines Agency) and Canadian-Health
  2. Presentations with voice-over and detailed online material
  3. A mix of quizzes for practice, quizzes as test, Discussion based questions and various job-related exercises, along with solutions.
  4. Learn on-demand, upgraded content that helps you stay up to date.
  5. Applying Concept into Real-time (Policies, governance and tools)
  6. Earn a Course Completion Certificate to showcase in your resume
Curriculum
Overview of Clinical Trial Protocol
Phase IV Trials and Pharmacovigilance
Understanding of 21 CFR Part 11 and HIPAA
ICH Good Clinical Practice Guidelines
Drug Safety Regulation and Guidelines
Drug Safety Data Extraction & pre-processing
SOP Development
Revision of SOPs
  • Curriculum Overview