Step into the role of a Clinical Research Associate! This course covers clinical trial management, regulatory compliance, and data quality. Master the skills to monitor trial sites, ensure patient safety, and support groundbreaking research—your career in clinical research starts here.
Gain a deep understanding of the entire medicines development lifecycle, from research to regulatory submissions.
Learn essential ICH GCP guidelines and navigate regulatory frameworks in the EU and USA, including FDA regulations.
Develop skills in designing study protocols, selecting and monitoring trial sites, and managing clinical data.
Master techniques for patient protection, adverse event reporting, and ensuring data quality and integrity.
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 offers a detailed understanding of how to assess and prepare clinical trial sites. You’ll learn to evaluate investigational sites, implement strategies for site enhancement, and conduct effective site initiation visits. These skills are essential for ensuring successful clinical trials and efficient site management.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the qualities of a good investigator site.
✓ Learn the purpose of an initiation visit.
✓ Plan and organise appropriate training for trial site staff.
✓ Follow up on identified issues and escalate problems as needed.
✓ Encourage investigator sites in patient recruitment using ethical methods.
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 provides crucial insights into monitoring and closing clinical trial sites. You’ll learn how to assess site performance, conduct effective monitoring and close-out visits, and develop strategies to address any issues that arise. These skills are essential for maintaining the integrity and efficiency of clinical trials.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the purpose of monitoring.
✓ Prepare and conduct effective monitoring visits.
✓ Follow up on identified issues and escalate problems as needed.
✓ Assess site performance and develop strategies for improvement where needed.
✓ Prepare and conduct effective close-out visits.
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 focuses on securing patient safety and handling adverse events in clinical trials. You’ll gain a thorough understanding of the informed consent process, adverse event identification and reporting, and strategies to protect patient confidentiality and data integrity. These skills are essential for maintaining ethical standards and compliance in clinical research.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Know how to encourage investigator sites to conduct patient recruitment ethically.
✓ Verify that the informed consent process has been properly performed and documented.
✓ Understand factors affecting patient safety and data integrity at investigator sites.
✓ Comprehend adverse event reporting 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 module covers the comprehensive management of investigational medicinal products (IP). You will learn about drug accountability, storage, dispensing, and documentation. The module also addresses randomization and blinding procedures, ensuring compliance with protocols, and FDA inspection findings. These skills are critical for maintaining the integrity and safety of clinical trials.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the key aspects of investigational product management.
✓ Learn the responsibilities of the Sponsor, Monitor, and Investigator.
✓ Conduct IP reconciliation at the end of the trial.
✓ Understand randomization and blinding processes.
✓ Monitor IP-related aspects during visits (drug accountability, storage conditions, etc.).
✓ Familiarize with common findings from FDA inspections.
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 provides essential knowledge on managing clinical trial data effectively. You will learn about the structure and purpose of Case Report Forms (CRFs), accurate data collection, compliance with data validation plans, and the documentation requirements for essential documents. These skills are critical for maintaining data integrity and ensuring regulatory compliance in clinical trials.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the purpose and structure of a Case Report Form (CRF).
✓ Learn the process for accurate data collection.
✓ Ensure that the investigator site is aware of the requirement of archiving essential documents in accordance with applicable guidelines and regulations.
GAVIN CHAIT
Data Scientist at Whythawk
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.
The typical responsibilities of a CRA can vary depending on the employer, the stage of the clinical trial, and the size of the study team. However, some common responsibilities of a CRA may include:
Overall, the role of a CRA is multifaceted and requires a high level of attention to detail, organization, and communication skills.
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 Research Associate
| 5 star | 92% | |
| 4 star | 5% | |
| 3 star | 3% | |
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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
