Clinical Trials MasterClass

The Clinical Trials MasterClass is for everyone who is new to clinical research. Even without any related background, this MasterClass will get you ready for entry level jobs in the clinical research industry.

Description

A Flexible Online Setup

Our setup enables you to complete this MasterClass either next to a full-time job or in a focused effort. 100% of the MasterClass is online and most of the training courses can be completed at any time.

Get Certified & Job Ready

On successful completion of this MasterClass , 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 roles in clinical research.

The VIARES Clinical Trials MasterClass is more than just a training. It’s a life-changer!

Certificates:

  • VIARES, GCP

 

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • 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
  • any time free cancellation of monthly payment

Course Content

The Clinical Trials MasterClass consists of 25 consecutive modules. You will complete each module by:

  • taking your e-learning
  • submitting your assignment work
  • completing your module test

25 Modules – up to 200 Learning Hours –  Certificates.

Successfully complete the 25 competency modules below to obtain your VIARES Clinical Trials MaserClass Certificate.

  • What is clinical research
  • How are clinical trials managed
  • Who can participate in clinical trials
  • What are the key phases and roles in clinical trials
  • ICH GCP E6(R2) Certificate
  • Investigator Oversight
  • 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
  • SSU structure, responsibilities and involvement in project life-cycle
  • Main groups of core study submission documents
  • Core documents required for submissions
  • Documents development responsibilities
  • Core submission package
  • Critical path for efficient start up
  • Country level documents for submission
  • Country documents development responsibilities
  • Country adaptations
  • ICFs / Assents requirements, adaptation and GDPR
  • Labels
  • Translation requirements
  • Site level documents
  • Country submission packages
  • VHP process and timeliness
  • VHP submission process vs. regular country submission process – differences
  • VHP advantages and disadvantages
  • VHP PLUS
  • Upcoming regulations
  • Protocol Amendments in VHP
  • Main regulatory bodies and their responsibilities
  • Submission strategies and dependencies (main groups on diagrams)
  • Submissions and approval timelines
  • Comments, conditional approvals, rejections
  • EudraCT study registry
  • EudraCT GMP database
  • EudraCT Annex 1
  • EudraCT Annex 2
  • EoT notification form
  • Upcoming EU regulation
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing
  • Background of monitoring concepts
    • Including on-site, remote, and statistical monitoring
  • Regulatory guidance to remote and statistical monitoring
  • Monitoring concepts in the framework of risk-based monitoring
  • From concept to reality: Remote monitoring and centralized statistical monitoring
  • Daily Life of a Remote Monitor
    • Responsibilities
    • Tools and resources
    • How to handle centralized statistical monitoring
    • Monitoring activity and their focus
    • Documentation and follow-up
    • Team interactions
  • What makes a good Remote Monitor
  • Setting clear goals and expectations is the crucial first step when it comes to your job search.
  • Understand WHAT are the required skills of your dream job and how to acquire them 
  • you will address THE most important piece to get your dream job
  • As often, it’s more about preparation and practice than any other “miracle tip”. There is no secret – however, there is a good way to prepare correctly for any interview (a method), and this method works well.
  • Negotiate and Get What You Truly Deserve.

Requirements

This MasterClass will be of benefit to anyone who is new to clinical research and who wants to start a fulfilling clinical research career.

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

Joanna Wilinska Mackowiak

Andreas
Beust

Hear from our graduates

Joe-Henry

Joe-Henry

It was a great experience to have gone through the VIARIES Clinical Research Talent Program, which was a breath taken opportunity for me as the course gave me the opportunity to broaden my perspective in regards to the dynamics of

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clinical research. The online learning platform was very informative, well organized, and very inspiring for the future Clinical Research professionals. I particularly enjoyed the online webinars and assignments, which made the content understandable. I strongly recommend it to all folks interested in the field of clinical Research. Finally, many thanks to Dietmar Eglhofer and team for ensuring to provide quality t raining.

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Veronica

Veronica

VIARES is a great summary of shared clinical expertise and insights made available to enlarge the view on clinical research or move the first step in this field. Strongly suggested.Thank you VIARES.

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Clinical Trials MasterClass
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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.

      BARTEK JAROSZ

      18 Years experience

      Bartek has 18 years experience in clinical research business, mostly spent at largest global Contract Research Organizations. At Quintiles he was responsible for pioneer development of clinical start-up and regional contract departments. He served as executive member of clinical start-up leadership team at INC Research, acting as global head of site contract division. His most recent experience includes support for pharmaceutical organizations in various project specific roles. Bartek enables biopharma to get their sites up and running faster. He is author of several training programs about site contract related matters and successfully delivered to hundreds of individuals worldwide.

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