Clinical Research Fundamentals

Get to know Clinical Research

The VIARES Clinical Research Fundamentals program is more than just training.

We aim to improve employability as Clinical Research Professionals for our participants. Our setup enables participants to complete their program next to a full-time job or in a focused effort. On successful completion of this program graduates will have acquired basic knowledge about medicines development and related regulations and apply your skills to work in the exciting field of Clinical Research. Enjoy all our services during your program enrollment.

  • modules including
    • e-learnings
    • assignments
    • knowledge checks
    • pre-recorded webinars
  • VIARES ACADEMY certificate
  • GCP certification
  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • VIARES ACADEMY certificate
  • GCP certification
  • Talent Profile to connect you with open jobs
  • Talent Days to connect with our industry partners and learn about career opportunities
  • Talent Portal to apply for posted jobs available to the Talent Program Community

Program

The Clinical Research Fundamentals program consists of three consecutive modules. You will complete the following learning activities:

  • review the e-learning
  • submit the assignment
  • watch the pre-recorded webinar
  • take the module test 

You can start the program immediately after your enrollment. Successfully complete all modules 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
  • 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
  • applicable national and international regulatory requirements including ICH GCP E6 (R2)
  • requirements for audits and inspections
  • need of compliance in all activities of your future professional work
  • sponsor’s obligation to develop and implement a quality assurance system including company-specific Standard Operating Procedure (SOPs)
  • skills required before, during and after inspections/audits
  • ability to recognise and deal with misconduct and suspected fraud
  • The CTA as member of the clinical study team
  • Typical activities of the CTA related to:
    • Managing Essential Documents
    • Handling Investigational Medicinal Product
    • Supporting Data Management
    • Interaction with Ethics Committees and Regulatory Bodies

Expert instructors​

Eric Klaver
Gabriele Disselhoff

Who should attend

This program will be of benefit to anyone aiming to start a career in Clinical Research. You should have a life science degree or first work experience (not necessarily in clinical research).

Is this academy right for me? We are happy to help you make the right decision.
Email us at academy@theviares.com and we will contact you.

Typical jobs with this skills

You could apply for jobs like:

  • Clinical Trials Assistant
  • Clinical Project Assistant
  • Clinical Operations Specialist and similar starting roles in clinical research

Affordable and flexible

  • Our Talent Programs come at very affordable cost wherever you are in your career.
  • Choose from multiple payment options to adjust to your personal preferred payment schedule.
  • Invite your friends with your personal discount code to sign up and get refunded.

Not yet ready to invest in your career? Sign up to our email list and we’ll keep you updated about our upcoming academy dates!

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Clinical Research Fundamentals

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