CRA Academy

Full service for 12 months

Enjoy all our services during your enrollment.

  • 8 modules including
    • 19 e-learnings
    • 15+ assignments
    • 9 knowledge checks
  • PREMIUM ONLY
    • up to 32 instructor-led live webinars and recordings
  • VIARES CRA ACADEMY certificate
  • GCP certification
  • PREMIUM ONLY
    • one year ACRP membership including access to all member services
    •  ACRP certification enrollment
  • we optimize your application documents and build your candidate brand
  • we proactively promote you within our industry and partner network, improving your chance to get interviewed
  • we connect you with open jobs to speed up your job search

Academy Program & Webinars

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 to obtain your CRA ACADEMY certificate.

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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • October 10, 2019
  • December 05, 2019

Pricing

PREMIUM: Euro 1.990, or 12 monthly installments at Euro 199,- (incl. Austrian VAT), includes

  • One year ACRP membership including all membership services
  • One ACRP certification
  • Instructor support
  • Live webinars
  • Access to all recorded webinars

Standard: Euro 1.490, or 12 monthly installments at Euro 149,- (incl. Austrian VAT)

Who should attend

This academy will be of benefit to anyone aiming to start a career as Clinical Research Professional. If you have a university degree in life sciences or natural sciences, and at least two years of 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.

Listen to previous participants

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