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Clinical Research Project Specialist

Get the basics on clinical research, regulations and new skills in project management , stakeholder management, project planning,…

Description

A Flexible Online Setup

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 Project Specialst or similar.

The VIARES Clinical Research Project Specialist 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
  • get your personal career coaching
 

Course Content

The VIARES Clinical Research Project Specialist program consists of ten consecutive modules. You will complete the following learning activities:

  • review the e-learning
  • submit the assignment
  • take the module test
  • review instructor-led recorded webinars

10 Modules – 100 Learning Hours – VIARES & GCP Certificate.

Successfully complete the 10 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
  • 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
  • Get familiar with project management terminology.
  • Define project success criteria.
  • Set up project phases correctly.
  • Choose fitting tools to manage a project.
  • Communicate efficiently while managing a project.
  • Understand typical differences between the PM’s role depending on the company type.
  • Understand the stakeholder landscape.
  • Analyse stakeholders.
  • Identify key stakeholders.
  • Communicate successfully with different stakeholders choosing adequate style, frequency, and the level of detail.
  • Understand the project external and internal environment.
  • Assess how the environmental factors affect the project.
  • Define requirements to make the project a success story.
  • Define the project scope.
  • Build a strong project definition.
  • Obtain the approval for your project definition.
  • Differentiate risks, constraints, and issues.
  • Identify project risks and decide on a suitable primary response strategy.
  • Analyse project risks in three dimensions – likelihood, impact, and detectability.
  • Quantify risks and calculate the Risk Priority Number.
  • Optimise conditions for high risks.
  • Monitor risks and keep them under control.
  • Assess the effectiveness of your risk management process.
  • Identify key stages of a project.
  • Analyse whether something is missing for a successful delivery (gaps).
  • Plan how to bridge the gaps.
  • Assign responsibilities to your team members.
  • Develop the clinical study budget.
  • Prepare a detailed realistic plan (baseline schedule) of the project including milestones, critical path, work breakdown, and allocated resources.
  • Use a well-designed baseline schedule to measure progress and manage the project in the execution phase.

Requirements

This program will be of benefit to anyone with a bachelor degree in life science degree and/or first relevant work experience, ideally in clinical research, pharma or related areas, e.g. working with patients, medical products or services, medical technology, laboratories or similar.

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.

Hear from our graduates

Sitakshi

Sitakshi

It was a great opportunity taking part in the VIARES clinical research talent program to build and upgrade my clinical research skills. Since the course offers a nice balance between online webinars, recorded lectures and homework’s which allow us

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to deepen our understanding and apply the concept in real life approach. The program was well organized and excellently structured where the topic was taught by experts in the field. Hence, I am proud to announce that I have successfully passed the final exam and would recommend to those, who is seeking a rewarding carrier in clinical research. I personally thank to Mr. Dietmar Eglhofer and team for running this amazing platform and giving us the opportunity to be a part of VIARES Academy.

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Marina

Marina

I am grateful to VIARES Academy for giving me a deeper insight into the CRA role and responsibilities. I have learnt a lot of useful aspects of the role and I believe this will help me in my future career.

[expand]

Thanks to Team of the VIARES Academy for putting together this great program!

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reviews curated by judge.me

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Clinical Research Project Specialist
This Course includes

£ 139.00

£ 15.00 / month for 12 monthsPay monthly

    SOMMER SPECIAL - GET 50% OFF THE 2nd COURSE
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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.

      KAMILA NOVAK

      certified Lead Auditor for ISO 9001:2015

      Kamila Novak, MSc, has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant in medical writing, auditing, training, project and risk management. She delivered dozens of courses in areas related to clinical research and project management. In August 2019, Kamila became a certified Lead Auditor for ISO 9001:2015. Kamila is a Core Team Member in the DIA GCP & QA, Clinical Research, and Project Management Communities.

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