Clinical Trials MasterClass

The Clinical Trials MasterClass is for everyone who is new to clinical research. Even without any related background, this MasterClass will get you ready for entry level jobs in the clinical research industry.


Successfully complete the 25 competency modules below to obtain your VIARES Clinical Trials MasterClass Certificate.
  • What is clinical research
  • How are clinical trials managed
  • Who can participate in clinical trials
  • What are the key phases and roles in clinical trials
  • ICH GCP E6(R2) Certificate
  • Investigator Oversight
  • 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
  • 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
  • Effective Monitoring
    • Planning, Conducting, Documenting, and Reporting Monitoring Visits
    • Managing Issues
  • Closing Investigational Sites
    • Organizing the Close-Out Visit
    • Documentation
    • Reporting
  • 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
  • Data Collection
    • Clinical Research Form (CRFs)
    • Process of Data Collection
    • Data Collection Systems
  • Data Validation
    • Data validation process
    • Query Process
    • Data Quality Assurance
  • 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
  • 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 250 questions from the VIARES training course. You need to complete the exam within 180 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.

  • Background of monitoring concepts
    • Including on-site, remote, and statistical monitoring
  • Regulatory guidance to remote and statistical monitoring
  • Monitoring concepts in the framework of risk-based monitoring
  • From concept to reality: Remote monitoring and centralized statistical monitoring
  • Daily Life of a Remote Monitor
    • Responsibilities
    • Tools and resources
    • How to handle centralized statistical monitoring
    • Monitoring activity and their focus
    • Documentation and follow-up
    • Team interactions
  • What makes a good Remote Monitor
  • Setting clear goals and expectations is the crucial first step when it comes to your job search.
  • Understand WHAT are the required skills of your dream job and how to acquire them 
  • you will address THE most important piece to get your dream job
  • As often, it’s more about preparation and practice than any other “miracle tip”. There is no secret – however, there is a good way to prepare correctly for any interview (a method), and this method works well.
  • Negotiate and Get What You Truly Deserve.


This MasterClass will be of benefit to anyone who is new to clinical research and who wants to start a fulfilling clinical research career.

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 and we will contact you.

why should I become a clinical research professional?

  • There are several potential reasons why you might consider becoming a clinical research professional, including:
  • Contributing to medical advances: By working in clinical research, you have the opportunity to contribute to the development of new treatments and therapies that can improve people’s lives.
  • Job growth and stability: Clinical research is a growing field with many job opportunities, and the demand for skilled professionals is likely to continue to increase in the future.
  • Competitive salaries: Many jobs in clinical research offer competitive salaries, and with experience and advanced education or certifications, you may be able to earn even more.
  • Career variety: Clinical research involves many different types of roles and responsibilities, which can provide you with the opportunity to explore different areas of interest and develop a diverse set of skills.
  • Intellectual challenge: Clinical research involves a significant amount of critical thinking, problem solving, and attention to detail, which can be intellectually stimulating and rewarding.


Overall, becoming a clinical research professional can be a fulfilling and rewarding career path for those who are interested in contributing to medical research and improving patient outcomes.

what are the typical responsibilities of an entry level clinical research role?

The specific job responsibilities of an entry level clinical research role can vary depending on the position and the employer. However, here are some common job responsibilities that you might expect to encounter in an entry level clinical research position:

  • Assisting with protocol development: Entry level clinical research professionals may be responsible for helping to develop study protocols, which describe the goals, methods, and procedures for a clinical trial or research project.
  • Preparing study documents: This may include preparing informed consent forms, case report forms, and other study documents necessary for the conduct of a clinical trial.
  • Coordinating study visits: Entry level clinical research professionals may help coordinate patient visits and assist with data collection during these visits.
  • Managing study data: This can include entering data into electronic databases, performing quality checks on the data, and generating reports as needed.
  • Assisting with study recruitment: Entry level clinical research professionals may help with recruiting and screening study participants.
  • Managing study supplies: This can include ordering and organizing study supplies, such as medications or lab kits.
  • Assisting with regulatory compliance: Entry level clinical research professionals may assist with ensuring that the study is conducted in compliance with applicable regulations and guidelines.

Overall, entry level clinical research roles often involve a mix of administrative and clinical tasks, and may require working collaboratively with a variety of team members to ensure that the study is conducted effectively and efficiently.


To become a clinical research professional, there are several educational and experiential backgrounds that can be helpful, including:

  • Education: A bachelor’s or master’s degree in a relevant field such as life sciences, nursing, or medicine can be helpful. Some employers may also prefer candidates with a degree in a related field, such as statistics or public health.
  • Clinical experience: Many clinical research positions require prior clinical experience, such as working as a nurse, medical assistant, or physician. This experience can provide valuable insight into the patient experience and medical care delivery.
  • Research experience: Experience working on research projects, such as in a lab or academic setting, can be helpful in demonstrating an understanding of the research process.
  • Regulatory experience: Experience working with regulatory bodies such as the FDA can be valuable for clinical research professionals working in areas such as clinical trial management or regulatory affairs.
  • Computer skills: Clinical research professionals should be comfortable using computers and various software programs, including electronic data capture (EDC) systems and statistical analysis software.

Overall, a combination of education and experience can be helpful for those seeking a career in clinical research. It’s important to stay up-to-date with the latest industry trends and regulations, and to continually seek out opportunities to develop your knowledge and skills in this rapidly-evolving field.

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 and we will contact you.


Obtaining a Clinical Research certification can provide several potential benefits, including:

  • Professional recognition: A Clinical Research certification demonstrates to employers and colleagues that you have the knowledge and skills necessary to excel in your role as a clinical research professional.
  • Competitive edge: In a competitive job market, having a Clinical Research certification can set you apart from other candidates and increase your chances of being hired or promoted.
  • Career advancement: With a Clinical Research certification, you may be eligible for higher-paying and more advanced roles in the field.
  • Increased knowledge and skills: Pursuing a Clinical Research certification can help you gain a deeper understanding of clinical research methods, regulations, and ethical considerations, which can help you perform your job more effectively.

Overall, obtaining a Clinical Research certification can be a worthwhile investment for those who are committed to their career in clinical research and interested in advancing their knowledge and skills.


A Flexible Online Setup

Our setup enables you to complete this MasterClass either next to a full-time job or in a focused effort. 100% of the MasterClass is online and most of the training courses can be completed at any time.

Get Certified & Job Ready

On successful completion of this MasterClass , you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Associate, In-House Clinical Research Associate or similar roles in clinical research.

The VIARES Clinical Trials MasterClass is more than just a training. It’s a life-changer!




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

Your expert instructors

Joanna Wilinska Mackowiak


Hear from our graduates



The VIARES Academy provided insight into the medicine development process, ICH GCP guidelines for designing trials, and safety and ethical considerations. This training provided a streamlined, comprehensive overview of the clinical trials


process and I would recommend it to anyone interested in this field.




The VIARES Clinical Research Talent Program was a fantastic opportunity to gain and update on new knowledge in the field of Clinical Research encompassing Clinical Trials, Clinical Data Management and Clinical Data Regulations. Overall it


was a very good experience with quite intensive learning and an amazing learning and skill development opportunity.


Customer Reviews

Based on 2 reviews
Sylvie Robichaud

😍 i love it ,just got a new job in Research it helps me ….thank you ! So far so good…


Proud to announce that I have passed the Final Exam on the VIARES Clinical Research Talent Program. I strongly recommend it to all people interested in the field of clinical trials. Of course many thanks to Dietmar Eglhofer for creating this programand all the great tutors: Eric Klaver, Gavin Chait and Gabriele Disselhoff.

reviews curated by



Clinical Trials MasterClass
This Course includes

£ 99.90

£ 9.90 / month for 12 monthsPay monthly


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.


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.


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.

Explore our pricing plans

For fast-learners!

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


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...


For fast-learners!
Pay monthly
  • Free cancellation every month
  • 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


Learn at your own pace!
Life-time 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...

Request Course outline

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