CRA Academy

Start your career in clinical research as a Clinical Research Associate!

Learn all the technical skills to become a Clinical Research Associate from experienced top industry trainers.

The academy provides an intensive and practice-oriented training to entry-level CRAs in line with the comprehensive IAOCR competency framework. It provides ICH GCP E6 (R2) training recognized by TransCelerate. The program is also aligned with competency frameworks and profiles from the Global Health Network, the Academy of Clinical Research and the UK Cogent Skills Council.

After completing our academy, the door will open to exciting job opportunities and career perspectives, the chance to work in a multi-disciplinary and multi-cultural environment, an opportunity to contribute to better health care and apply technical skills combined with professional skills and behaviors.

The program will be regularly reviewed and updated by our industry expert instructors.

You can start the academy any time and complete it at your own pace. Your training content is ready for you today and you have access for 12 months. Join our regular webinars with industry expert instructors to discuss real-life cases or listen to recordings of previous sessions. Successfully complete eight competency modules and obtain your CRA ACADEMY certificate.

CRAs are in high demand – we assume that every year about 20.000 new CRAs are needed. Currently over 600 entry level CRA roles are advertised in Europe and 6.000 in the USA. So, join us and launch your career today!

Who should attend

This academy will be of benefit to anyone aiming to start a career as Clinical Research Associate. If you have a university degree in life sciences, and clinical research or study site work experience, you will get the most out of it.

Your work experience could be as a Clinical Trial Assistants, Study Site Coordinator, Project Associate, Data Specialist, TMF Coordinator, Study Nurse, or similar roles.

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

Academy Program & Webinars

Learning Elements:

  • 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

Learning Outcomes

  • Describe the medicines development lifecycle and the significant stages in evaluating the efficacy and safety of new treatments
  • Describe the principles of GCP and how it serves to protect patient safety and data integrity

Next Live Webinar Dates

  • July 22, 2019
  • September 16, 2019
  • November 11, 2019

Learning Elements:

  • 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

Learning Outcomes

  • Understand the design features of a clinical trial
  • Describe the rational of complying with any given study protocol in terms of protecting the rights and wellbeing of the patients and the integrity of the data
  • Understanding the roles and responsibilities of each of the key parties in a clinical research activity

Next Live Webinar Dates

  • July 25, 2019
  • September 19, 2019
  • November 14, 2019

Learning Elements:

  • Patient Protection
    • Patient Information
    • Collecting Patient Consent
    • Special Patient Populations
  • Adverse Event Reporting
    • Types of Adverse Events
    • Identifying and Reporting Serious Adverse Events

Learning Outcomes

  • Know how to encourage investigator sites to conduct patient recruitment in an ethical manner
  • Understand how to verify that the process of obtaining informed consent has been adequately performed and documented and that confidentiality was protected for each trial subject
  • Understand factors that might affect patient safety and clinical data integrity at an investigation such as protocol departures/violations and pharmacovigilance issues
  • Understand the reporting requirements for adverse events

Next Live Webinar Dates

  • July 29, 2019
  • September 23, 2019
  • November 18, 2019

Learning Elements:

  • Selecting an Investigational Site
    • Assessing Investigational Sites
    • Training and Upgrading Investigational Sites
  • Initiating Investigational Sites
    • Organizing the Initiation Visit
    • Setting up the required documentation – Essential Documents

Learning Outcomes

  • Understand the qualities of a good investigational site
  • Understand the purpose of an initiation visit
  • Know how to plan and organize appropriate training for trial site staff
  • Preparing and maintaining the Trial Master File and the Site Master File

Next Live Webinar Dates

  • August 01, 2019
  • September 26, 2019
  • November 21, 2019

Learning Elements:

  • Effective Monitoring
    • Planning, Conducting, Documenting, and Reporting Monitoring Visits
    • Managing Issues
  • Closing Investigational Sites
    • Organizing the Close-Out Visit
    • Documentation
    • Reporting

Learning Outcomes

  • Know how to conduct and document the key activities associated with a monitoring visit
  • Verify that all protocol-specific procedures are carried out by the investigational site staff
  • Follow up on identified issues and manage problems as needed
  • Write accurate and comprehensive monitoring reports
  • Understand the process involved in closing out an investigator site

Next Live Webinar Dates

  • August 05, 2019
  • September 30, 2019
  • November 25, 2019

Learning Elements:

  • 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

Learning Outcomes

  • Understand the key aspects of investigational (medicinal) product management
  • Describe the key measures that are taken to protect patients in the manufacture, packaging, labelling and distribution of investigational (medicinal) products
  • Verify the adequacy of the investigational (medicinal) products‘ storage conditions at the investigator site
  • Perform accountability/reconciliation of investigational (medicinal) product for an investigator site

Next Live Webinar Dates

  • August 08, 2019
  • October 03, 2019
  • November 28, 2019

Learning Elements:

  • Data Collection
    • Clinical Research Form (CRFs)
    • Process of Data Collection
    • Data Collection Systems
  • Data Validation
    • Data validation process
    • Query Process
    • Data Quality Assurance

Learning Outcomes

  • Understand the purpose and structure of a Case Report Form (CRF)
  • Understand the process for accurate data collection
  • Ensure that the investigator site is aware of the requirements of archiving essential documents in accordance with applicable guidelines and regulations

Next Live Webinar Dates

  • August 12, 2019
  • October 07, 2019
  • December 02, 2019

Learning Elements:

  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections

Learning Outcomes

  • Know and understand the applicable regulatory requirements including ethics reviews and the related processes, obligations and timelines
  • Know and understand what a quality assurance system implies and how it impacts the CRA work – including SOPs
  • Understand the difference between audits and inspections and possess the skills required to handle each.
  • Be able to identify and manage instances of fraud and misconduct

Next Live Webinar Dates

  • August 15, 2019
  • October 10, 2019
  • December 05, 2019

Pricing

Sign up Euro 899,- plus 12 monthly academy subscriptions each Euro 99,- (incl. Austrian VAT)

Services included:

  • 12 months full access to the academy
    • instructor-led live webinars
    • all recorded webinars
    • all e-learing material
  • VIARES CRA ACADEMY certificate
  • GCP certification
  • access to our career services

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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CRA Academy

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