Prepare for your next role in clinical research.
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Gain comprehensive knowledge of the medicines development lifecycle, from initial research to regulatory submissions and lifecycle management.
Understand and apply the ICH GCP guidelines, along with regulatory requirements in the EU and USA, including compliance and quality assurance.
Develop essential skills for clinical trial design, understanding roles and responsibilities, and ensuring ethical compliance in clinical research.
Master the key responsibilities of a Clinical Trials Assistant, including managing essential documents, handling investigational products, and supporting data management and regulatory interactions.
This first module will help you build a strong foundation in the clinical research field. You’ll explore the key stages of medicines development, from research and discovery to clinical trials and regulatory submissions. Additionally, you’ll master the principles of Good Clinical Practice (GCP) to ensure patient safety and data integrity throughout your research.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the background of medicines development and its critical processes.
✓ Learn about the research and discovery stages, and how product development progresses.
✓ Explore the phases of clinical development and their significance.
✓ Gain insights into regulatory submission, Health Technology Assessment, and lifecycle management.
✓ Master ICH GCP and other applicable regulations essential for clinical research.
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
In this module, you’ll dive into the intricate regulatory environments of the EU and USA. You’ll gain an in-depth understanding of the national and international regulatory requirements, including ICH GCP E6 (R2), and learn the importance of compliance in your professional work. This module will equip you with the necessary skills to handle audits, inspections, and to develop robust quality assurance systems.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the significance of regulatory requirements in clinical research.
✓ Learn about the regulatory systems in the USA and EU.
✓ Master the monitor’s role in audits and inspections.
✓ Recognize and deal with misconduct and suspected fraud.
✓ Develop skills required before, during, and after inspections/audits.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
This comprehensive module provides an in-depth understanding of clinical trial design and the various roles and responsibilities within clinical research. You’ll delve into the critical components of a study protocol, explore diverse trial design methodologies, and gain insights into the ethical and regulatory frameworks that govern clinical research. Master the skills necessary to ensure the integrity and success of your clinical trials.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the design features of a clinical trial.
✓ Describe the rationale of complying with any given study protocol to protect patient rights and ensure data integrity.
✓ Learn the roles and responsibilities of each key party in clinical research activities.
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
This module will provide you with a comprehensive understanding of the Clinical Trial Assistant (CTA) role within a clinical study team. You’ll explore the typical activities of a CTA, including managing essential documents, handling investigational medicinal products, supporting data management, and interacting with ethics committees and regulatory bodies. By the end of this module, you’ll be equipped with the skills necessary to ensure clinical trial success.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the role of the CTA in the wider project team to ensure clinical trial success
✓ Learn about essential documents and how to support their maintenance according to ICH GCP
✓ Gain knowledge about the investigational medicinal product (IMP) and how to support its handling
✓ Understand data management requirements and how to support related processes
✓ Comprehend regulatory and IRB/IEC requirements and learn how to assist in fulfilling these requirements
KHILNA SAMAT
Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.
This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.
Explore the full curriculum in pdf and receive email reminders when enrollment closes:
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Yes. The course ends with the VIARES Clinical Trials Assistant certification exam: 40 questions, 60 minutes, pass mark 80 %. Two attempts are included and the higher score counts.
When you pass, you receive your personal VIARES certificate as a PDF, signed by our CEO Dietmar Eglhofer. Every certificate has a code that anyone (for example a recruiter) can check on the public VIARES certificate verification page. You also get a “Confirmation of Enrollment” as soon as you enrol. VIARES is IAOCR 5-star accredited (2018) and has issued more than 53,000 certificates.
The clinical trial assistant course takes about 50 hours of learning. It is 100 % online and self-paced, with no fixed schedule, so you can complete it next to a full-time job or in a focused effort.
Each module combines microcourses, a practical assignment and a knowledge check (pass mark 70 %, unlimited attempts, 30 minutes each). You can take the final certification exam whenever you are ready.
The course is built for newcomers to clinical research who want to start in an entry-level role such as Clinical Trial Assistant: graduates in life sciences, nursing, pharmacy or healthcare, and career changers from other fields. All modules are beginner level, so no prior clinical research experience is required.
Before the first module you complete two short pre-work e-learnings (a free ICH GCP course from The Global Health Network and the TransCelerate Investigator Oversight module) to set your baseline.
Not sure if this is the right training for you? Email us at academy@viares.com and we will get back to you.
A clinical trial assistant (CTA) supports the clinical study team so that a trial runs smoothly and in line with ICH GCP. Typical CTA tasks include:
Read more in our guide What does a clinical trial assistant do?
CTA (Clinical Trial Assistant): supports the sponsor or CRO study team with documentation, the TMF, meetings, tracking and submissions. It is a typical entry role into clinical research.
CRA (Clinical Research Associate): the monitor. A CRA oversees the investigator sites on behalf of the sponsor and checks that the protocol and GCP are followed and that the data are accurate. Many CTAs move on to a CRA role; see our Clinical Research Associate course (80–100 hours).
CRC (Clinical Research Coordinator): works at the investigator site (hospital or clinic) and coordinates the study day to day, from participant visits to site documentation; see our Clinical Study Coordinator course.
Advanced Training Modules + VIARES Study Guide + Certification Exams. Lifetime Access to Unmatched Curriculum:
Original price was: € 199,90.€ 99,90Current price is: € 99,90.
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IAOCR-accredited (2018), industry-recognized certification with a practitioner-built curriculum. Seminars, assignments and exams tailored to your need to stay ahead and stand out for the new job role! 100% Money-back Guarantee with 5 Day Refund Policy.
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We pride ourselves on high-quality programs. That’s why we offer a 5-day no-questions-asked 100% money-back guarantee. If for any reason you are unhappy, you will get a full refund.
Your membership to VIARES includes everything you need to excel in your clinical research career.
Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.
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Develop the latest and most in-demand clinical research skills with 100% online, industry-recognized courses.
VIARES is known by the world’s leading organizations for clinical research providing you with the best training for your future dream job!
With VIARES you also get support with finding your clinical research dream job.
VIARES’ digital certificates are a proven way to showcase that you mastered a new skill and upgrade your resume to land your next dream job.
Clinical Trials Assistant
Verified ownerno help available
Verified ownerHighly recommend the TMF Specialist Certification!I recently completed the Trial Master File Specialist Certification through VIARES Academy, and it exceeded my expectations. The course structure is incredibly clear and well-paced, breaking down complex regulatory standards, compliance metrics, and document management rules into practical, real-world examples. The training is highly practical, up to date with global industry standards, and easy to follow. The self-paced modules and assignments truly prepare you for the current clinical research job market. I feel completely confident moving forward in my clinical operations career. Thank you, VIARES!
Verified ownerwonderful
Verified ownerI am very satisfied with the course.Best money investment, especially for the beginners as me.
Verified ownerEducative indeed
Verified ownerI highly recommend this All-in-One Clinical Research course to anyone who wants to start or develop a career in clinical trials. The course is very well structured, easy to follow, and covers a wide range of important topics, including Clinical Trial Assistant responsibilities, Study Start-Up, Trial Master File (TMF), Clinical Trial Management, GCP principles, communication skills, regulatory requirements, and many practical examples from the industry.
What I appreciated most is that the instructors explain complex concepts in a clear and practical way, making the content suitable even for beginners while still providing valuable insights for professionals with previous healthcare experience.
Thanks to this training, I feel much more confident for interviews and much better prepared to begin my career in Clinical Operations. The knowledge is directly applicable to real-world clinical research, and the materials can be revisited whenever needed.
If you are serious about entering the clinical research industry, this course is definitely a worthwhile investment. Thank you to the Viares Academy team for creating such a comprehensive and high-quality learning experience.
Verified ownerThank you very much for the updated information on the ICG GCP E6 (R3) on your website. Quality information at a very nominal cost.
Verified ownerThe minicourses on all the listed topics were very useful to my students and me.
Verified ownerthe course was amazing. well tailored and knowledgeable expertise.
