Study Start Up Specialist Training
Study Start Up Specialist Training

More than a Training

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 Study Start Up Specialist or similar.

The VIARES Study Start Up Specialist 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.

  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • VIARES ACADEMY certificate
  • GCP certification
  • Optimize your CV
  • Create the best application
  • Prepare for the interview
  • Weekly new Global Jobs
  • Skip the Application Line
  • Join Career Events

Training fees temporarily reduced​

Our plans have two things in common – they cover your individual needs and are affordable.

Your program cost:

  • 12 month program subscription, 12 times €29.90 €19.90 per month

SAVE 17% if you choose to pay the subscription in one payment of €299 €199.

The subscription 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
  • VIARES and GCP certificates upon successful completion of the end-term exam
  • life-time VIARES membership and access to exclusive job offers and job services
  • ELKA test and exam from ACRP (Association of Clinical Research Professionals)
  • one year free membership with ACRP
  • 2 free sessions of Application Services
  • membership-lifteime access to more jobs

7-Day Guarantee

It’s risk-free to join this VIARES training course as you’re protected through a full 7-day money-back guarantee:

If you’re not completely satisfied with the training we’ll give you a full, unconditional refund.

Training Program

The Study Start Up Specialist program consists of nine modules. You will complete the following learning activities:

  • review the e-learning
  • submit the assignment
  • take the module test
  • take the final exam

9 Modules – 100 Learning Hours – 3 Certificates.

Successfully complete the 9 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
  • 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

Download the full Study Start Up training program to view more details about each module and view testimonials from past participants.

Elizabeth R
VIARES Graduate
"I found the VIARES Study Start Up Specialist program extremely informative and educational.""
Jodie B. VIARES Graduate

Planning

You can start the training right away and complete it at your own pace. This training contains 100 hours of online material and you have up to 12 months to complete it.

You do not need to wait for a kick-off date, you can start your training anytime  – as early as today if you wish.

Your expert trainers

Bartek Jarosz
Gabriele Disselhoff
Eric Klaver

Who should attend

This program will be of benefit to anyone with a life science degree and first relevant work experience, ideally but not necessary in clinical research or related areas.

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.

If you are not ready yet

Not quite ready yet? Make sure to keep in touch. Enter your information and we will let you know about our Career Events, special offers, and more. 

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Join Today to Save

20% off - from all training fees

For any new Training Sign-Up
  • reduced training fees
  • for one-time payments and 12 months payment plans
Until 31 JAN
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up to 43% off - from all training fees

For any new Training Sign-Up
  • reduced training fees
  • for one-time payments and 12 months payment plans
Until 31 DEC
Days
Hours
Minutes
Seconds

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"I found the VIARES Study Start Up Specialist program extremely informative and educational."
Jodie B
VIARES Graduate