Clinical Research Fundamentals

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role in clinical research.

COURSE Content

Successfully complete the 4 competency modules below to obtain your VIARES Clinical Research Fundamentals Certificate.

ICH GCP

Investigator Oversight
ICH GCP E6(R2)

Medicines Development Process, Good Clinical Practice

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

Regulatory Environment in the EU and USA

Applicable international and national regulations
ICH GCP E6 (R2)
FDA Regulation
Quality Assurance: Audits and Inspections

Clinical Trial Design & Clinical Research Roles and Responsibilities

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

VIARES CERTIFICATE

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

course title
contact hours
continuing education units (CEU)
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 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.

Delivered by industry experts

Hear from our graduates

Magda

The Viares Clinical Research Academy Talent Program was an exceptional experience! I would never think that online learning can be so well developed and structured. As a person with no monitoring experience, the Academy helped me to

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understand and also built my confidence in the Clinical Research. I feel well prepared to get my first job in this field. Many thanks to Dietmar Eglhofer, the whole team and all amazing tutors who made this program so professional. It was a great opportunity to gain new knowledge and I would recommend it to anyone interested in the field of clinical trials.

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Brisilda

Following my passion for clinical research and developing my career in this field, VIARES ACADEMY has played an incredible role, with the opportunity to be enrolled in such extraordinary, structured, well-organized, and dynamic training programs, led by

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Clinical Research Professionals. Recently, I have been a graduate in Clinical Research Project Management Program, after CRA Talent program in April 2020. Definitely, from both programs, I have gained the skills of learning and thinking at the same time through assignments and knowledge checks. As Confucius said: “Learning without thinking is useless, thinking without learning is dangerous“

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The VIARES Clinical Research Academy Program offers a great way to learn the basics of clinical research and monitoring. I am now confident in my knowledge and ready to take the next steps on this path. The VIARES team is always there to guideyou and the experienced tutors are keeping you focused while presenting the informative courses. Thank you VIARES for the opportunity to take part in this exciting program!

Detailed course outline

The instructors approach.

Best course I ever did

I tried other courses in the industry, but this is by far the most advanced. I‘m already invited for some job interviews 👍🏽

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How could I benefit from understanding the basics of clinical research?

Understanding the basics of clinical research can provide you with the knowledge and tools to critically evaluate health information, make informed decisions about healthcare, and communicate effectively with healthcare providers. Additionally, it can help you better understand the scientific process behind medical treatments and interventions, which can help you make more informed decisions about participating in clinical trials or other medical research studies. It can be helpful for a variety of careers in the healthcare and medical research fields, for example:

Medical professionals, such as doctors, nurses, and pharmacists, who understand clinical research can use the latest evidence-based practices to provide better patient care.
Researchers who are familiar with clinical research methods can design and conduct studies that are more likely to produce accurate and reliable results.
Regulatory professionals who understand the requirements for clinical trials can help ensure that trials are conducted ethically and in compliance with applicable laws and regulations.
Professionals in the pharmaceutical and biotech industries can use their understanding of clinical research to develop and market new treatments and products more effectively.

Overall, understanding the basics of clinical research can help you stay up-to-date with the latest advances in healthcare and can provide you with a competitive edge in your career.

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.

IS THIS THE BEST OPTION FOR ME?

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 academy@viares.com and we will contact you.

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Clinical Research Fundamentals

Typical annual market salary:
starting from $38,000

€ 24,90 / month for 12 months

€ 149,90Life-Time

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Clinical Research Fundamentals

COURSE Content

VIARES CERTIFICATE

Delivered by industry experts

Gabi Disselhoff

GAVIN CHAIT

Hear from our graduates

Magda

Brisilda

Customer Reviews

How could I benefit from understanding the basics of clinical research?

why should I become a clinical research professional?

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

IS THIS THE BEST OPTION FOR ME?

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Clinical Research Fundamentals

COURSE Content

VIARES CERTIFICATE

Delivered by industry experts

Gabi Disselhoff

GAVIN CHAIT

Hear from our graduates

Magda

Brisilda

Customer Reviews

How could I benefit from understanding the basics of clinical research?

why should I become a clinical research professional?

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

IS THIS THE BEST OPTION FOR ME?

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