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Clinical Research Associate
Content: Medicines Development Process, Good Clinical Practice, Regulatory Environment in the EU and USA, Clinical Trial Design & Clinical Research Roles and Responsibilities, and much more!
Learning: 80-100 hours online and self-paced, 8 Modules, Final Exam
Certificates: GCP, Get Cognitio, ACRP
Prerequisites: ideally life science education and first work experience
pay in 12 monthly installments or save with our optional 1-time payment
Payment: Pay in 12 monthly installments or save with our optional 1-time payment.
It’s Not Just A Course
It’s A Self-Paced Online Setup
Our online course setup enables you to complete this program either next to a full-time job or in a focused effort. 100% of the program is online and most of the training courses can be completed at any time and at your own pace.
Get Certified & Job Ready
On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Associate, In-House Clinical Research Associate or similar.
The Get Cognitio Clinical Research Associate program is more than just a training. It’s a life-changer!
The Training includes access to all Academy Services, and an industry recognized Professional Certification.
Access to all Academy Services
Modules including:
- e-learnings
- assignments
- knowledge checks
Industry Recognized Professional Certification
- Get Cognitio Certificate
- GCP Certification
ACRP ELKA and Membership
- ACRP Entry Level Knowledge Assessment certificate (ELKA)
- One year free ACRP Membership
5 Steps Guide to Get Your Dream Job
- Set clear goals
- Get properly trained
- CV, CV, CV
- Ace Your Interview
- Negotiate
Global Clinical Research Jobs
- Weekly new Global Jobs
- Skip the Application Line
- Join Career Events
Course Program
The Clinical Research Associate Program consists of eight consecutive modules. You will complete each module by:
- Taking your e-learning
- Submitting your assignment work
- Reviewing pre-recorded webinars
- Completing your module test
- Taking the final exam
8 Modules – 100 Learning Hours – 3 Certificates.
Successfully complete the 8 competency modules below to obtain your Get Cognitio Certificate.
In addition to VIARES lifetime membership, you will get a 1-year free membership with ACRP. You will also be able to take ACRP’s new ELKA (Entry-Level Knowledge Assessment) test. Upon successful completion, you will receive ACRP’s endorsement (ELKA certificate) of their foundational competencies required for entry-level roles in clinical research.
Medicines Development Process, Good Clinical Practice
- Background of medicines development
- Research and discovery stage & product development
- Clinical development
- Regulatory submission, Health Technology Assessment, lifecycle management
- ICH GCP and other applicable regulations
Regulatory Environment in the EU and USA
- Applicable international and national regulations
- ICH GCP E6 (R2)
- FDA Regulation
- Quality Assurance: Audits and Inspections
Selecting and Initiating Clinical Trial Sites
- Selecting an Investigational Site
- Assessing Investigational Sites
- Training and Upgrading Investigational Sites
- Initiating Investigational Sites
- Organizing the Initiation Visit
- Setting up the required documentation – Essential Documents
Monitoring and Closing Clinical Trial Sites
- Effective Monitoring
- Planning, Conducting, Documenting, and Reporting Monitoring Visits
- Managing Issues
- Closing Investigational Sites
- Organizing the Close-Out Visit
- Documentation
- Reporting
Patient Protection & Adverse Events
- Patient Protection
- Patient Information
- Collecting Patient Consent
- Special Patient Populations
- Adverse Event Reporting
- Types of Adverse Events
- Identifying and Reporting Serious Adverse Events
Investigational Medicinal Product Management
- Managing the Investigational Medicinal Product
- Definition of investigational medicinal product (IMP) / study drug
- Provision of the IMP
- Drug Accountability
- Randomization, blinding and un-blinding processes
- Managing Expiry Dates
- Collecting IMP after Site Close-out
Data Management for Clinical Research Associates
- Data Collection
- Clinical Research Form (CRFs)
- Process of Data Collection
- Data Collection Systems
- Data Validation
- Data validation process
- Query Process
- Data Quality Assurance
Start today
You can start the training right away and complete it at your own pace. This training contains 100 hours of online material.
You do not need to wait for a kick-off date, you can start your training anytime – as early as today if you wish.
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
Who Should Attend the Course
This program will be of benefit to anyone with a life science degree AND/OR first relevant work experience, ideally in clinical research, pharma or related areas, e.g. working with patients, medical products or services, medical technology, laboratories or similar.
If you are not sure if this is the right training for you, we are happy to help you make the right decision.
Email us at info@getcognitio.com and we will contact you.
Course fees
The fee includes:
- Registration fee
- All online-training course material, 100% online available in our learning management system
- Module check points (mini-exams during the training to test your knowledge)
- End-term exam
- Get Cognitio and GCP certificates upon successful completion of the end-term exam
plus exclusive Get Cognitio benefits:
- Get automatically accepted as Ambassadors and earn cash
- Join career events at no cost
- Free access to our weekly updated global job list
- Apply to exclusive job offers
- Get your personal career coaching
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Get the knowledge and resources you need to land your dream job in clinical research.
