The First Self-Paced Clinical Research Training Course with 110 Modules
CLINICAL RESEARCH CERTIFICATION ONLINE
Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care. As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree. This is why a career as a CRA should be considered with clinical research coordinator training. We train over 100 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).
A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders. Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain. While many generic courses exist on the market; we have seen that many of these students cannot find a job afterwords because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 110 intense modules. This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. We have the largest number of clinical research courses online.
Nonetheless, for those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career. Because the position is unlike actually working in the lab and requires a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.
Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered). Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year; an amount that is not common in other science-degree careers.
Many CRA students are actually matriculated foreign doctors who opted not to take the USMLE or repeat their residency training. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. and questioning what to do with an MBBS degree in US.
Unlike what you’ve learned during your 3-8 years in university or graduate school; the information needed for Clinical Research Training after your degree. Is rarely a repetition of any course you’ve taken before and thus we have 110 Clinical Research Training modules (more than any other course available) to make you get the position you want as a CRA.
ICH GCP TRAINING
The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.
15 MODULES
1. An Introduction to Clinical Research
2. An Overview of ICH GCP
3. Code of Federal Regulations
4. FDA 21 CFR Part 11 ( Part 1 and 2)
5. ICH GCP E6 Section 5 – Sponsors Responsibilities
6. ICH GCP E6 Section 4 – Investigators Responsibilities
7. ICH GCP E6 Section 4 – Investigators Responsibilities – Informed Consent Form
8. Reporting Responsibilities of the Investigators
9. Ethics of Research Involving Children
10. Ethics of Research Involving Mentally Incapacitated
11. Ethics of Research Involving Pregnant Women and Fetuses
12. Ethics of Research Involving Prisoners
13. ICG GCP 5.5 Trial Management – Data Handling and Record Retention
14. ICH GCP E6 and E2A – Adverse Events
15. Safety of Human Subjects in Clinical Research
Reference Modules – to be used for reference purposes only:
a) Common Terminology Used In Clinical Research
b) Commonly Used Abbreviations and Terms in Clinical Research
QUALITY MONITORING
The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.
45 MODULES
1. Duties and Responsibilities of a Clinical Research Associate
2. Designs of Clinical Trials
3. Phases of Clinical Trials
4. Pre-Clinical Trials
5. Stakeholders in Clinical Research and Their Relationships
6. Contract Research Organization- CRO
7. Randomized Controlled Trials
8. Types of Monitoring Visits
9. Site and Investigator Selection
10. Site Qualification Visit
11. Routine Monitoring Visit
12. Monitoring Tools and Notes
13. Checklists for Pharmacy Monitoring and Inspection Visits
14. Site Close Out Visit
15. Source Documents
16. Inclusion Exclusion Criteria in Clinical Research
17. Interactive Voice Response System – IVRS
18. Protocol in Clinical Research
19. Protocol Deviations and Violations
20. Institutional Review Board
21. Quality Control in Clinical Research
22. Data Safety Monitoring board- DSMB
23. An Overview of Remote Monitoring
24. Centralised Versus Onsite Monitoring
25. Electronic Data Capture and Remote Data Capture Basics
26. Remote Monitoring of Clinical Trials and EMRs
27. Blinding in Clinical Trials
28. Communication between Blinded and Unblinded Staff
29. Investigational Product Storage and Dispensing
30. Investigational Product Accountability in Clinical Trials
31. Adverse Drug Reactions
32. Basics of Adverse Event Monitoring
33. Adverse Event Reporting
34. Risk Based Monitoring
35. Pharmacovigilance (Part 1)
36. Pharmacovigilance (Part 2)
37. Safety Reporting Requirements for Sponsor Investigators
38. Investigator Initiated Multi Center Trails
39. IND and NDA Process
40. Guidelines for Designing and Completing Case Report Forms
41. Do’s and Don’ts of a Case Report Form Design
42. Introduction to Bioresearch Monitoring (BIMO)
43. Clinical Trial Management System-CTMS
44. Minimising Source Data Queries in Clinical Trials
45. Role of Local and Central Labs in Clinical Trials
REGULATORY TRAINING
Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.
15 MODULES
1. Regulatory Documents in Clinical Research
2. Regulatory Affairs
3. Essential Regulatory Documents Guidance and Binder Tabs -Part 1
4. Essential Regulatory Documents Guidance and Binder Tabs – Part 2
5. Electronic Regulatory Submission and Review
6. Financial Disclosure- Duties and Strategies for Clinical Studies
7. Financial Disclosures and Conflicts of Interest in Clinical Research
8. FDA Form 1572 – Part 1
9. FDA Form 1571 – Part 2
10. Delegation of Authority Log – DOAL
11. Investigators Brochures
12. Protocol Continuing
13. IND Application
14. Trial Master File Reference Guide
15. Trial Master File and DIA Model
AUDIT AND INSPECTIONS
The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organisation, or academic organisation after your Clinical Research Training.
6 MODULES
1. Audits and Inspections in Clinical Trials
2. FDA Warning Letter
3. Site FDA Audit Inspection Checklist
4. How to Survive Through an FDA Inspection
5. Do and Don’ts during an FDA Inspection
6. Mock FDA Audits
SUBJECT RECRUITMENT, RETENTION AND COMPLIANCE
5 MODULES
1. Compliance Requirements in Clinical Trials
2. Subject Recruitment and Retention (Part 1 and Part 2)
3. Increasing Subject Compliance in Clinical Trials
4. Ethical Consideration Associated with Investigator Payment and Patient Recruitment
5. Advertisement aid in Subject Recruitment and Retention
MISCONDUCT AND FRAUD
2 MODULES
1. Scientific Misconduct in Research and How to Prevent It
2. Misconduct in Research – Detecting Falsification
WRITING QUALITY MONITORING REPORTS & FOLLOW UP LETTERS
These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.
16 MODULES
1. Site Monitor Transition Letter
2. Checklist of Activities for Pre-Study Visit Qualification
3. Pre-study Visit Assessment and 4. Monitoring Questionnaire
5. Pre-Study Visit Follow Up Letter
6. Site Initiation Visit Agenda
7. Site Initiation Visit Confirmation Letter
8. Site Initiation Visit Report
9. Site Initiation Visit Follow Up Letter
10. Site Monitoring Visit Confirmation Letter/Fax
11. Site Monitoring Visit Report
12. Site Monitoring Visit Follow Up Letter
13. Site Close Out Visit Confirmation Letter
14. Site Close Out Visit Agenda
15. Site Close Out Visit Report
16. Site Close Out Visit Follow Up Letter
COMPETENCY TESTING FOR A CRA
The competency testing of your Clinical Research Training modules is the next step needed to ensure that you are ready for your interviews. We establish our CRA’s as future leaders in the clinical trial industry by ensuring you have the full education needed to be promoted in your career quicker than without the course.
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