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Study Start Up Specialist

Content: Medicines Development Process, Good Clinical Practice, Regulatory Environment in the EU and USA, Clinical Trial Design & Clinical Research Roles and Responsibilities, Start Up and core submission documents, Country level documents for submission, VHP process and timeliness, EudraCT, IP release document requirements, …

Learning: 80-100 hours online and self-paced, 9 Modules, Final Exam

Duration: 8-10 weeks

Certificates: GCP, VIARES

Prerequisites: ideally life science education or first work experience

319.90  99.90 or 12x 11.90

More than a Course

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!

  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • Set clear goals
  • Get properly trained
  • CV, CV, CV
  • Ace Your Interview
  • Negotiate
  • Weekly new Global Jobs
  • Skip the Application Line
  • Join Career Events

Course 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 on top.

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

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.

Your expert instructors

Gabriele Disselhoff VIARES Clinical Research Associate Training Expert Instructor
Eric Klaver VIARES Clinical Research Associate Training Expert Instructor

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 and we will contact you.

Course Fee

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
  • personalized attendance confirmation upon completion

plus exclusive VIARES benefits:

  • get automatically accepted as Ambassadors and earn credits
  • 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


  • get VIARES certified, by adding your Certification Exam to your training course
  • includes VIARES Exam of 100 question online test

Jobs matching this Course

This is a snapshot of 10 latest new entries from our full list of 5,225 Global Clinical Research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs.

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Request Course outline

Get a PDF of all training details to view more details about each module and view testimonials from past participants:

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