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Clinical Research Associate

Medicines Development Process, Good Clinical Practice, Regulatory Environment in the EU and USA, Clinical Trial Design & Clinical Research Roles and Responsibilities,…
  • Duration: 8-10 weeks
  • Learning: 80-100 hours online and self-paced
  • Certificates: GCP, VIARES, ACRP

Description

A Flexible Online Setup

Our 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.

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 VIARES Clinical Research Associate program is more than just a training. It’s a life-changer!

Certificates:

  • VIARES
  • GCP
  • ACRP ELKA
 

The fee includes:

  • registration fee
  • all online-training course material
  • one year online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam of 100 question
  • personalized certificate upon completion
 

plus exclusive VIARES benefits:

  • 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
  • one year free ACRP membership upon completion of the VIARES certificate

Course Content

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

8 Modules – 100 Learning Hours – 3 Certificates.

Successfully complete the 8 competency modules below to obtain your VIARES Academy Certificate.

  • 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
  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections
  • The Study Protocol
    • Elements of a Study Protocol according to ICH GCP
    • Trial Design
    • Methodologies
  • Roles and Responsibilities
    • Ethics Committees
    • Sponsor / Monitor
    • Investigator
    • Competent Authority
  • 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
  • Effective Monitoring
    • Planning, Conducting, Documenting, and Reporting Monitoring Visits
    • Managing Issues
  • Closing Investigational Sites
    • Organizing the Close-Out Visit
    • Documentation
    • Reporting
  • Patient Protection
    • Patient Information
    • Collecting Patient Consent
    • Special Patient Populations
  • Adverse Event Reporting
    • Types of Adverse Events
    • Identifying and Reporting Serious Adverse Events
  • 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 Collection
    • Clinical Research Form (CRFs)
    • Process of Data Collection
    • Data Collection Systems
  • Data Validation
    • Data validation process
    • Query Process
    • Data Quality Assurance

Requirements

  • ideally life science education or first work experience

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 academy@viares.com and we will contact you.

Your expert instructors

Eric Klaver

Gabi Disselhoff

GAVIN CHAIT

Hear from our graduates

Zlatko

Zlatko

I really enjoyed the VIARES CRA Academy. The course is well structured and covers all relevant aspects to prepare you for a job in clinical research. In addition, guidelines for CV optimization and job applications are included. I’ve completed several

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courses in clinical research and I can confirm that VIARES offers the best quality.

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Darina

Darina

I am very grateful for the opportunity to participate in the VIARES Clinical Research Talent program. The program is well developed and structured. Courses, knowledge checks, assignments and webinars are very useful for understanding

[expand]

the whole clinical trial process. I have learned a lot of new things. I will definitely use it in my career. I recommend it to anyone who is interested in the field of clinical trials.

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Customer Reviews

Based on 19 reviews
89%
(17)
11%
(2)
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z
zh shah

Clinical Research Associate

K
Kelvin Ogega
Informative Training

The course is rich and relevant, contributing significantly to the development of ideas and knowledge. It's easy to use, even amid a hectic daily routine, and you have the freedom to set your own pace. It's informative and professional!

A
Andres Lannepoudenx
Great course

It helped me a lot. The classes and the material are very good. I recomend It.

I
Irina Kukova
Useful, Interesting, satisfying

Congratulations on a well-organized training, the platform works flawlessly, and is filled with meaningful and useful content that builds ideas and knowledge, adds significant value. Convenient to use even for very busy everyday life and the freedom to choose your own training schedule. It's just professional and perfect!

O
Oluwatoba Fadeyi
Great CRA training.

The structure and training format at Viares is stimulating and engaging. The microcourse, assignment and knowledge check actually help to deepen the know-how on clinical research. As a result of completing this program, I am more confident I will succeed as clinical research associate by applying the knowledge gained from the courses offered at Viares.

123

reviews curated by judge.me

-57%

BESTSELLER

Clinical Research Associate
This Course includes
  • Language - English
  • Access on desktop, tablet and mobile
  • One year access
  • Certificate of Completion
Download course outline PDF

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      ERIC KLAVER

      Trained in 6 continents

      Eric brings with him 20 years of experience training and meeting management and has worked in clinical research for almost 25 years. The global reach of this experience (Eric has trained in six continents) makes him the partner of choice to work with. Eric combines soft skills with personal responsibility in every training.

      GAVIN CHAIT

      Data Scientist at Whythawk

      Gavin Chait is a Data Scientist at Whythawk, which specializes in integrated open data consulting, and training for open knowledge, freedom of information, and economic development projects. He spent more than a decade in economic and development initiatives in South Africa. He was a commercial director at the Open Knowledge Foundation, and led the implementation of numerous open data projects around the world. Gavin has twenty years of experience in teaching at all academic levels, and is a passionate advocate for knowledge development through open access to data and freedom of information.

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