Cross Over Program
Clinical Research Assistant

The Cross Over Program Clinical Research Assistant (xCRS) is specifically designed for anyone new to clinical research. With or without a life-science education or work experience. This Cross Over Program will help you to cross the path from your current job into the clinical research industry.


  • industry required competencies for a Clinical Research Assistant role including
    • introduction to clinical research
    • understanding GCP and general regulatory requirements
    • trial monitoring support and administration
    • setup, maintenance and archiving of a trial master file
    • including investigator site file and pharmacy site file
    • Start Up and core submission documents
    • ICFs / Assents requirements, adaptation and GDPR
    • EudraCT and upcoming EU regulations
    • IP release document requirements
    • and much more
  • a proven process to prepare your job application
    • identify your dream job
    • understand what are the requirements and how to meet them
    • create a clear and concise CV
    • prepare your interview
    • negotiate your package
  • 4 personal coaching sessions with our talent specialist
    • find the right job for you
    • define your application strategy and actions
    • optimize your communication and information
    • prepare for your interview

You can start your program any time after purchase and define your own pace with our online setup. This is ideal for anyone with a current employment.

Program Competencies

  • 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
  • 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
  • The CTA as member of the clinical study team
  • Typical activities of the CTA related to:
    • Managing Essential Documents
    • Handling Investigational Medicinal Product
    • Supporting Data Management
    • Interaction with Ethics Committees and Regulatory Bodies
  • Background of TMF management
  • The importance of documentation within a clinical trial
  • Basic insights into the TMF structure and its content 
  • Main tasks and responsibilities of a TMF Specialist
  • Detailed insights into the TMF structure and its content
  • Essential documents 
  • Detailed insights into the TMF set up and its index
  • Document Management Plan
  • TMF Archiving
  • The importance of documentation within a clinical trial
  • Basic insights into the ISF structure and its content
  • Basic insights into the PSF structure and its content 
  • 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

Application process

  • 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.

Personal coaching

  • set a realistic job goal
  • match your goal with your skills and competencies
  • be clear about your strength and weaknesses
  • select the target jobs to apply for
  • define what you need to do to be successful in your application
  • align your information and your documents to match the requirements of the selected target jobs
  • ensure your skills and competencies are clearly understandable and meet your real situation
  • send your application to the right recipient via the right media
  • once you are invited to an interview, we will do a preparation interview with you
  • simulate the situation and understand what could come to you


Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the program and your exam, you get your personal “xCRS Certificate” including:

  • course title
  • contact hours
  • continuing education units (CEU)
  • your overall course score
  • date of completion
  • personal certificate verification code

We also show you how to best share your certificate on LinkedIn and other social media platforms.

Obtaining your xCRS 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.

Your expert instructors



TMF Specialist



Clinical Document Management Expert

Hear from our graduates



I have successfully completed the VIARES Clinical Research Talent Program, allowing me to expand my clinical research skills. The program has informative micro-courses and webinars which are organized. This program provided me with deep


insights into clinical research. I highly recommend it to anyone interested in the field of Clinical Research.




I am very pleased that got the chance to attend the VIARES Clinical Research Talent program. The online learning platform was very informative, well organized, and very encouraging for the future Clinical Research professionals. I particularly


enjoyed the online webinars and assignments, which made the content easily understandable by discussing simultaneously with the experts in the field.

I would like to thank everyone in the Viares team who was involved in the preparation and execution of the training. I look forward to attending future training given the opportunity.


reviews curated by

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.



Cross Over Program
Clinical Research Assistant
Typical annual market salary:
$38,000 to $105,000+
This Course includes


 29,90 / month for 12 monthsPay monthly


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.


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.


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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  • Plan ends automatically after 12 payments
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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


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...


pay as you go
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  • 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


one payment - unlimited access
  • All benefits from the monthly payment plan
  • Life-time access to your purchased course
  • Life-time support from the VIARES team
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