Clinical Research Associate Certification

Clinical Research Associate Certification Canada

Interested in becoming a Clinical Research Associate(CRA)?

What is a Clinical Research Associate?

A CRA ensures that medical devices, new drugs, and new treatments are approved for patients' use. CRAs also have training in assisting clinical researchers and investigators in the, coordination, administration, and management of clinical trials. Individuals certified in this role have knowledge of the following topics: safety procedures, subject recruitment, drug development, trial management, accountability, regulatory requirements, and medical terminology.
Affordable and Accredited Certification

It can be hard to break into the fields of medical research and patient care without prior experience. CCRPS is one of the only major US-based ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma accredited CRA Certification courses that takes on students with no prior background experience related to the certification. The course is affordable and can be completed in as little as 7 days.
Adapted for those looking become a CRA in Canada

Clinical Research Associate Certification Canada covers ICH GCP, Quality Monitoring, Regulatory affairs, Site Open-Close Out, and specific Canadian guidelines required for Clinical Research Associates to enter the Canadian workforce.

CRA CERTIFICATION

CCRPS offers an accredited Clinical Research Associate Certification made for anyone looking to break into the field of clinical/medical research. It provides a more efficient avenue for professionals who want to advance or start their career with a CRA Certification. Unlimited access to the course is provided for a year from the date of purchase and a Certificate is provided upon completion of the course. The cost can be paid as a single installment of $695.00, two monthly installments of $347.00, three monthly installments of $231.00, four monthly installments of $173.00, five monthly installments of $139.00, or six monthly installments of $133.00. A free preview is also available for those still wondering if the course is right for them.

Purchase Free Preview

Want to learn more about being a Clinical Research Associate?

Follow our guide here:

CCRPS CLINICAL RESEARCH ASSOCIATE GUIDE

Course Curriculum

107 self paced modules

1. Accreditation Statement
2. CME Handout
1. 1. An Introduction to Clinical Research
  FREE PREVIEW
2. 2. An Overview of ICH GCP
3. 3. Code of Federal Regulations
4. 4. FDA 21 CFR
  FREE PREVIEW
5. 5. ICH GCP E6 Section 5 - Sponsors Responsibilities
6. 6. ICH GCP E6 Section 4 - Investigators Responsibilities
7. 7. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form
  FREE PREVIEW
8. 8. Reporting Responsibilities of the Investigators
9. 9. Ethics of Research Involving Children
10. 10. Ethics of Research Involving Mentally Incapacitated
11. 11. Ethics of Research Involving Pregnant Women and Fetuses
12. 12. Ethics of Research Involving Prisoners
13. 13. ICH GCP 5.5 Trial Management – Data Handling and Record Retention
  FREE PREVIEW
14. 14. ICH GCP E6 and E2A - Adverse Events
15. 15. Safety of Human Subjects in Clinical Research
16. a) Common Terminology Used In Clinical Research
17. b) Commonly Used Abbreviations and Terms in Clinical Research
18. ICH GCP Quiz
1. 1. Duties and Responsibilities of a Clinical Research Associate
  FREE PREVIEW
2. 2. Designs of Clinical Trials
3. 3. Phases of Clinical Trials
4. 4. Pre-Clinical Trials
5. 5a.Stakeholders in Clinical Research and Their Relationships
6. 5b.Stakeholders in Clinical Research and Their Relationships Video
7. 6.Contract Research Organization- CRO
8. 7a.Randomized Controlled Trials
9. 7b.Randomized Controlled Trials Video
10. 8.Types of Monitoring Visits
11. 9a.Site and Investigator Selection
12. 9b.Site & Investigator Selection
13. 10.Site Qualification Visit
14. 11a.Routine Monitoring Visit
15. 11b.Routine Monitoring Visit Video
16. 12.Monitoring Tools and Notes
17. 13.Checklists for Pharmacy Monitoring and Inspection Visits
  FREE PREVIEW
18. 14a.Site Close Out Visit
19. 14b.Site Close Out Visit
20. 15.Source Documents
21. Quality Monitoring Quiz Modules 1-15
22. 16. Inclusion Exclusion Criteria in Clinical Research
23. 17. Interactive Voice Response System - IVRS
24. 18.Protocol in Clinical Research
25. 19a.Protocol Deviations and Violations
26. 19b. Protocol Deviations and Protocol Violations Video
27. 20.Institutional Review Board
28. 21a.Quality Control in Clinical Research
29. 21b. Quality Control In Clinical Research Video
30. 22. Data Safety Monitoring board- DSMB
  FREE PREVIEW
31. 23a. An Overview of Remote Monitoring
32. 23b. An Overview of Remote Monitoring Video
33. 24. Centralized Vs. Onsite Monitoring
34. 25. Electronic Data Capture and Remote Data Capture Basics
35. 26.Remote Monitoring of Clinical Trials and EMRs
36. 27.Blinding in Clinical Trials
37. 28. Communication between Blinded and Unblinded Staffsion
38. 29.Investigational Product Storage and Dispensing
  FREE PREVIEW
39. 30.Investigational Product Accountability in Clinical Trials
40. Quality Monitoring Quiz 16-30
41. 31.Adverse Drug Reactions
42. 32.Basics of Adverse Event Monitoring
43. 33.Adverse Event Reporting
44. 34.Risk Based Monitoring
45. 35.Pharmacovigilance Part 1
  FREE PREVIEW
46. 36.Pharmacovigilance - Part 2
  FREE PREVIEW
47. 37.Safety Reporting Requirements for Sponsor Investigators of An IND
48. 38.Investigator Initiated Multi-Center Trials
49. 39.IND and NDA Process
50. 40.Guidelines for Designing and Completing Case Report Forms
  FREE PREVIEW
51. 41. Do’s and Don’ts of a Case Report Form Design
52. 42.Introduction to the Bioresearch Monitoring Program (BIMO)
  FREE PREVIEW
53. 43. Clinical Trial Management System-CTMS
  FREE PREVIEW
54. 44.Minimizing Source Data Queries In Clinical Trials
55. 45.Local and Central Labs in Clinical Trials
56. Quality Monitoring Quiz 31-45
1. 1.Regulatory Documents in Clinical Research
2. 2.Regulatory Affairs
3. 3. Essential Regulatory Documents Guidance and Binder Tabs (Part 1)
  FREE PREVIEW
4. 4. Essential Regulatory Documents Guidance and Binder Tabs (Part 2)
  FREE PREVIEW
5. 5. Electronic Regulatory Submission and Review
  FREE PREVIEW
6. 6.Financial Disclosure- Duties and Strategies for Clinical Studies
7. 7.Financial Disclosures and Conflicts of Interest in Clinical Research
8. 8.FDA Form 1572 - Part 1
  FREE PREVIEW
9. 9.FDA Form 1572 - Part 2
10. 10. Delegation of Authority Log – DOAL
11. 11. Investigators Brochures
12. 12. Protocol Continuing
13. 13. IND Application
14. 14. Trial Master File and DIA Model
  FREE PREVIEW
15. 15. Trial Master File Reference Guide
16. Regulatory Training Quiz (20 Questions)
1. 1. Audits and Inspections in Clinical Trials
  FREE PREVIEW
2. 2. FDA Warning Letter
3. 3.Site FDA Audit Inspection Checklist
4. 4.How to Survive Through an FDA Inspection
5. 5.Do and Don’ts during an FDA Inspection
6. Audits and Inspection Quiz
1. 1.Compliance Requirements in Clinical Trials
2. 2a.Subject Recruitment and Retention (Part 1)
  FREE PREVIEW
3. 2b.Subject Recruitment and Retention (Part 2)
4. 3.Increasing Subject Compliance in Clinical Trials
5. 4.Ethical Consideration Associated with Investigator Payment and Patient Recruitment
6. 5.Advertisement Aid in Subject Recruitment and Retention
1. 1.Scientific Misconduct in Research and How to Prevent It
  FREE PREVIEW
2. 2.Misconduct in Research – Detecting Falsification
1. 1.Site Monitor Transition Letter
2. 2.Checklist of Activities for Pre-Study Visit Qualification
  FREE PREVIEW
3. 3.Pre-study Visit Assessment and Monitoring Questionnaire
4. 4.Pre-study Site Qualification Assessment
5. 5.Pre-Study Visit Follow Up Letter
6. 6.Site Initiation Visit Agenda
7. 7.Site Initiation Visit Confirmation Letter
8. 8.Site Initiation Visit Report
9. 9.Site Monitoring Visit Confirmation Letter/Fax
10. 10.Site Monitoring Visit Report
11. 11.Site Monitoring Visit Follow Up Letter
12. 12.Site Close Out Visit Confirmation Letter
13. 13.Site Close Out Visit Agenda
14. 14.Site Close Out Visit Report
15. 15.Site Close Out Visit Follow Up Letter
16. 16. REFERENCE Module
1. 1.Course Testimonial or Feedback
2. 2a.Resume Updating (Part 1)
3. 2b. Resume Updating (Part 2)
4. 2c. Resume Updating (Part 3 LOR)
5. 3. Recruitment and Job Placement Support
6. 4a.Interview Preparation (Part 1)
  FREE PREVIEW
7. 4b.Interview Preparation (Part 2)
  FREE PREVIEW
8. 4c.Interview Preparation (Part 3)
  FREE PREVIEW
1. Canadian Guidance Document Resources
2. Canadian Drug Guidelines
1. Competency Exam (52 Questions)

About this course

$800.00
133 lessons
1 hour of video content

FAQ

Who I can talk to if I want more information about the course?

You can reach out to us anytime via email at [email protected]
How long will I have access to the course?

You will have lifetime access to the course!
How long will my certification last?

Your certification is valid for one year and can be renewed by retaking the course exam!

CCRPS