Professional Training Course Package

6 Clinical Research Training Courses

Experience the full power of the VIARES clinical research training courses. Get upskilled on the most important professional competencies to advance your clinical research career.

Why advancing your Clinical Research career?

A Growing Industry

First, the clinical research industry is growing every year by 6-8%. In parallel, the global talent pool grows by about 4-5%, which provides great career opportunities. 

If you have the required degree and work experience, it’s your turn to become one of these knowledgeable experts!

 

Jobs That Pay Well

The number of job opportunities is currently growing. As an example salaries for CRA start at around €35.000 in Europe and $75.000 in the USA and go way above $100.000 per year.

Next to these starting salaries,  it is possible to take fast career pathways and gain more responsibilities rapidly. Promotions often come within 2-3 years into professional levels, taking salaries up to about €45.000 in Europe and $100.000+ in the USA.

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.

Get Certified & Job Ready

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to boost your clinical research career.

The training includes access to all academy services, and an industry recognized professional certification.

You can start the training right away and complete it within the given timelines at your own pace. This training contains over 400 hours of online material and you can complete it at your own pace.

You do not need to wait for a kick-off date, you can start your training anytime  – as early as today if you wish.

Requirements:

This program will be of benefit to anyone with a life science degree and 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.

Certificates:

  • VIARES, GCP, ACRP ELKA

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • 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
  • any time free cancellation of monthly payment
  • in addition you will get a 1-year free membership with ACRP. You will also be able to take ACRP’s new ELKA (Entry-Level Knowledge Assessment) test. Upon successful completion, you will receive ACRP’s endorsement (ELKA certificate) of their foundational competencies required for entry-level roles in clinical research.
 
 

WE TRAIN AND CERTIFY YOU

The VIARES Clinical Research PRO Package consists of 4 training courses. Successfully complete the courses to obtain four certificates.

CLINICAL RESEARCH PROJECT SPECIALIST

  • 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.

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

CLINICAL STUDY COORDINATOR II

  • ALCOA-CCEA Principles
  • Source DocumentsTypes
  • Correction Methods
  • Schedule of Events
  • Informed Consent Form (ICF)
  • Informed Consent Process
  • Elements of an ICF
  • Medical History
  • Source Documentation
  • Concomitant Medication (ConMeds
  • Schedule of Events
  • Source Documents
  • Inclusion/Exclusion Criteria
  • Eligibility
  • ConMeds
  • Medical History
  • Source Documentation
  • ConMeds
  • Medical History
  • Adverse Events (AE) and Serious Adverse Events
  • Day 3 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 7 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 14 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 28 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

STUDY START UP SPECIALIST

  • 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

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

CLINICAL OPERATIONS SPECIALIST

  • 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
  • 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
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing
  • 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.

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

BESTSELLER

Professional Training Course Package
Average Market Salaries:
above $45,000 p.a.
This Course includes

 249,90

 30,90 / month for 12 monthsRead more

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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.

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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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PATRICIA HOLLIS

in the industry for 21 years

Patricia has been in the clinical research industry for over 20 years. She began her career as a clinical research coordinator at the Medical College of Virginia where she coordinated pharmaceutical and PI initiated trials. She has been a Clinical Research Associate for 16 years and has had the opportunity to serve as a Lead CRA, Clinical Trial Manager, Auditor, Mentor, and Clinical Research Instructor. She has worked in all phases of research and is experienced in numerous therapeutic areas, including Oncology, Endocrinology, CNS, Immunology, Cardiology, Nephrology and Device. Currently, she is a contract CRA through her company, The Hollis Group, LLC, which she owns with her husband and serves as a consultant at local research sites. Patricia completed a Bachelor of Science degree at Virginia Commonwealth University, MBA at Texas Woman’s University and has had specialized oncology training from the Oncology of Nursing Society.

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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.

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Explore our pricing plans

For fast-learners!

1 YEAR ACCESS
Pay in 12 monthly INSTALLMENTS
  • One year access to your training courses
  • Plan ends automatically after 12 payments
  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
  • No training course handouts for offline learning
  • No unlimited access

UNLIMITED ACCESS

Learn at your own pace!
ONLY ONE Payment
  • All benefits from the montly payment plan
  • Life-time access to your purchased course
  • Training course handouts included
  • Life-time support from the VIARES tutors
  • And much more...
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Monthly

1 YEAR ACCESS
Pay in 12 monthly INSTALLMENTS
  • One year access to your training courses
  • Plan ends automatically after 12 payments
  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
  • No training course handouts for offline learning
  • No unlimited access

LIFETIME

one payment - unlimited access
ONLY ONE Payment
  • All benefits from the montly payment plan
  • Life-time access to your purchased course
  • Training course handouts included
  • Life-time support from the VIARES tutors
  • And much more...
Popular

Monthly

pay as you go
Completely Flexible
  • Control over your plan; you can cancel any time
  • Work at your own pace; set your own deadlines
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
  • Personalized certificate upon completion

LIFETIME

one payment - unlimited access
NO TIME LIMITS
  • All benefits from the monthly payment plan
  • Life-time access to your purchased course
  • Life-time support from the VIARES team
  • Free Handouts for all courses
Popular