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 as Clinical Trials Assistant or similar.
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. Learn from expert Eric Klaver and 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.
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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.
Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.
Develop the latest and most in-demand clinical research skills with 100% online and globally recognized courses.
VIARES is known by the world’s leading organizations for for clinical reasearch 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.
Becoming a Clinical Trials Assistant (CTA) can provide valuable experience in the healthcare and research industries, with potential for career advancement. You can contribute to the development of new treatments and therapies, while working in a dynamic and challenging environment. Additionally, the role can offer opportunities for personal growth and the satisfaction of helping improve healthcare outcomes for patients.
The salary for a CTA can vary based on factors such as location, experience, and employer. In the United States, the median annual salary for a clinical trials assistant is around $49,000, with a range typically falling between $38,000 to $62,000. However, salaries can be higher or lower depending on the specific job and its location. It’s always a good idea to research the specific job and employer you are interested in to get a better understanding of the salary range.
The job responsibilities of a CTA can vary depending on the employer and the specific role, but generally, a CTA works with the clinical research team to support the planning and execution of clinical trials. Here are some common job responsibilities of a CTA:
Assisting with trial coordination: CTAs may help with the coordination of trial-related activities, such as scheduling participant visits, preparing study materials, and managing study supplies.
Data entry and management: CTAs may be responsible for entering data into study databases, tracking study progress, and monitoring participant safety and data quality.
Regulatory compliance: CTAs may help ensure that trials are conducted in compliance with regulatory requirements and study protocols, which may include preparing regulatory submissions, maintaining study documentation, and assisting with audits or inspections.
Communication and collaboration: CTAs may work closely with other members of the clinical research team, such as study coordinators, investigators, and sponsors, and may also communicate with study participants and their families.
Overall, the job responsibilities of a CTA involve supporting the clinical research team and contributing to the successful completion of clinical trials, with a focus on accuracy, efficiency, and adherence to study protocols and regulations.
Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:
We also show you how to best share your certificate on LinkedIn and other social media platforms.
There are several reasons why you might consider getting a CRA certification:
Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.
Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.
Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.
Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.
Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.
No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).
To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.
In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.
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.
Clinical Trials Assistant
| 5 star | 92% | |
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| 1 star | 0% |
Verified ownerReally good work and presentations. I wish live also be a part of it. Otherwise the course is excellent
Verified ownerVIARES ACADEMY ALL-In-One Accelerator
Verified ownerClinical Research Associate Accelerator
Verified ownerClinical Research Associate
Verified ownerClinical Study Coordinator II
Verified ownerVIARES Micro Certificate DOUBLE-BLIND STUDY
Verified ownerCliniical Research associate Tutorials were very clear and tutors very friendly. Queries were responded to very promptly.
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
