CRA Academy

CRA Training and more​

The VIARES CRA ACADEMY is more than just training.

We aim to improve employability as Clinical Research Professionals for our participants. Our setup enables participants to complete their program next to a full-time job or in a focused effort. On successful completion of this program graduates will have acquired knowledge, skills and competencies to start at an entry level CRA role.

Enjoy all our services during your CRA Academy enrollment. 

  • 8 modules including
    • 19 e-learnings
    • 15 assignments
    • 9 knowledge checks
    • 8 instructor-led live webinars and recordings
  • VIARES CRA ACADEMY certificate
  • GCP certification
  • ACRP membership including access to all member services for one year and ACRP certification enrollment (a total value of USD 585)
  • 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

Flexible Plans

Our plans have two things in common – they cover your individual needs and are affordable.

You prefer to learn at your own pace and time? Then this plan is right for you to complete the CRA Academy.

The plan includes:

  • 8 self-learning modules
  • 19 e-learnings
  • 15 assignments
  • 9 knowledge checks
  • 12 months career service

You prefer to learn from your expert instructor on top of your self-paced learning experience? You are not sure about an industry certification for now? Then this plan is right for you to complete the CRA Academy and to decide on an industry certification later.

The plan includes:

  • 8 instructor led live webinars
  • instructor led modules
  • 19 e-learnings
  • 15 assignments
  • 9 knowledge checks
  • 12 months career service

You prefer to learn from your expert instructor on top of your self-paced learning experience? You want to get ACRP certified and differentiate you from other candidates for CRA job? Then this plan is right for you to complete the CRA Academy at your own pace and get additional insight from our experts. You can start your ACRP membership right after completion of the CRA ACADEMY and get prepared for the ACRP certification.

The plan includes:

  • ACRP Certification
  • 12 months ACRP Membership
  • 8 instructor led live webinars
  • 8 self-learning modules
  • 19 e-learnings
  • 15 assignments
  • 9 knowledge checks
  • 12 months career service

Academy Program​

The CRA Academy consists of eight consecutive modules. Depending on the selected plan you will complete each module by:

  • taking your e-learning
  • completing your module test
  • submit your assignment work
  • attending the instructor-led live webinar 

Your training content is ready for you today and you have access for 12 months. 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

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

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

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

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

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

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

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

Live Webinars

If you select the Instructor Led or the Certified plan you can join our webinars with industry expert instructors to foster your learning and discuss real-life cases with them. Every webinar will be run twice to allow you to join from most time zones. Join the time option that works best for you. If you miss a webinar, you can listen to the recording.

LIVE WEBINARS

DAY

TIME

Kick-Off

November 05, 2019

PDT 7:00 am, EST 10:00 am, CET 16:00

Medicines Development Process, Good Clinical Practice

November 11, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Clinical Trial Design & Roles and Responsibilities

November 14, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Patient Protection & Adverse Events

November 19, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Selecting and Initiating Clinical Trial Sites

November 21, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Monitoring and Closing Clinical Trial Sites

November 25, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Investigational Medicinal Product Management

November 28, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Data Management for Clinical Research Associates

December 02, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Regulatory Environment in the EU and USA

December 05, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

If you select the INSTRUCTOR LED or the CERTIFIED plan you can join our webinars with industry expert instructors to foster your learning and discuss real-life cases with them. The webinars are organized in blocks and will cover multiple modules. Every webinar will be run on a Saturday and allow you to join in various time zones. If you miss a webinar, you can listen to the recording.

LIVE WEBINARS

DAY

TIME

Kick-Off

November 05, 2019

START: 4pm CET, 10am EST, 7am PT

END: 5pm CET, 11am EST, 8am PT

BLOCK 1

Medicines Development Process, Good Clinical Practice

Clinical Trial Design & Roles and Responsibilities

Patient Protection & Adverse Events

November 16, 2019

START: 3pm CET, 9am EST, 6am PT

END: 6pm CET, 12am EST, 9am PT

BLOCK 2

Selecting and Initiating Clinical Trial Sites

Monitoring and Closing Clinical Trial Sites

Investigational Medicinal Product Management

November 30, 2019

START: 3pm CET, 9am EST, 6am PT

END: 6pm CET, 12am EST, 9am PT

BLOCK 3

Data Management for Clinical Research Associates

Regulatory Environment in the EU and USA

December 14, 2019

START: 4pm CET, 10am EST, 7am PT

END: 6pm CET, 12am EST, 9am PT

LIVE WEBINARS

DAY

TIME

Kick-Off

November 04, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Medicines Development Process, Good Clinical Practice

November 11, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Clinical Trial Design & Roles and Responsibilities

November 14, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Patient Protection & Adverse Events

November 19, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Selecting and Initiating Clinical Trial Sites

November 21, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Monitoring and Closing Clinical Trial Sites

November 25, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Investigational Medicinal Product Management

November 28, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Data Management for Clinical Research Associates

December 02, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Regulatory Environment in the EU and USA

December 05, 2019

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

LIVE WEBINARS

DAY

TIME

Kick-Off

January 03, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Medicines Development Process, Good Clinical Practice

January 07, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Clinical Trial Design & Roles and Responsibilities

January 14, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Patient Protection & Adverse Events

January 21, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Selecting and Initiating Clinical Trial Sites

January 28, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Monitoring and Closing Clinical Trial Sites

February 04, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Investigational Medicinal Product Management

February 11, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Data Management for Clinical Research Associates

February 18, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Regulatory Environment in the EU and USA

February 25, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

LIVE WEBINARS

DAY

TIME

Kick-Off

February 10, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Medicines Development Process, Good Clinical Practice

February 13, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Clinical Trial Design & Roles and Responsibilities

February 20, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Patient Protection & Adverse Events

February 27, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Selecting and Initiating Clinical Trial Sites

March 05, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Monitoring and Closing Clinical Trial Sites

March 12, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Investigational Medicinal Product Management

March 19, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Data Management for Clinical Research Associates

March 26, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

Regulatory Environment in the EU and USA

April 02, 2020

option 1: EST 7:30 am, CET 13:30

option 2: PDT 7:30 am, EST 10:30 am, CET 16:30

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, or first clinical research or study site work experience, you will get the most out of it.

Your degree can be in areas like Biochemistry, Biology, Biomechanics, Biomedical Science, Chemistry, Clinical Research, Medical Technology, Microbiology, Organic Chemistry, Pharmacy, Veterinary Science or similar.

Your work experience could be as a Research Nurse, Clinical Trial Assistants, Study Site Coordinator, Project Associate, Data Specialist, TMF Coordinator, Medical Sales Representative 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.

Want to learn more?

Listen to our previous participants!

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!

* indicates required

CRA Academy

You’re only 1 click away from changing your life. What are you waiting for? SIGN UP TODAY!

Close Menu
×
×

Cart