Study Start Up Specialist

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, …

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.

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.

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
 

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

Course Content

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

Requirements

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.

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

Hear from our graduates

Jun

Jun

The VIARES Clinical Research Academy program is a great opportunity to build the clinical research skills for not only CRAs but also every role involved in clinical research. As a physician, I have participated in several clinical trials in Asia in the role of

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personnel of investigator team. This structured and well-developed program has helped me to gain and refresh my professional knowledge in clinical research, especially the regulatory environment in the EU and USA. After graduating from this program, I am more confident in my professional career and believe I will be competent in other roles of clinical research as well. Many thanks to the VIARES team and all the tutors.

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Aparna

Aparna

The VIARES Talent Program opened the doors to the fascinating world of clinical trials and covered all aspects of the field. The course was very well-organized and detailed. The instructors were knowledgeable, enthusiastic, and provided real-world

[expand]

insights. The assignments really helped to internalize all we had learned throughout the course.

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Customer Reviews

Based on 2 reviews
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H
Humberto Salazar Angulo
Amazing

The information is very helpful. And everything is organized. I need your support. I need to send again an assignment. Could you please help me with that?

D
Daphne Reason

Hello,

I like the course very user friendly, I'm learn things that I didn't know and getting a refresher on things that I had forgetting. Also, I have submitted two assignment but I don't see a grade for them. I have also recommend a few colleague to take a few of the courses. Thank you.

reviews curated by judge.me

 
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Study Start Up Specialist
This Course includes

£ 159.90

£ 19.90 / month for 12 monthsPay monthly

    -50% for your 2nd training course
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      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.

      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.

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