VIARES Clinical Research Associate Academy
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 Research Associate, In-House Clinical Research Associate or similar.
What you will learn
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.
Why VIARES?
VIARES CRA ACADEMY
- 4 MODULES
- 18 LESSONS
- 5 CERTIFICATES
Module 1: Clinical Research FundamentalsBASICS
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
build a strong foundation in the clinical research field
This module serves as your gateway to understanding the fundamentals of Clinical Research Associate (CRA) roles. Through this module, you’ll gain a comprehensive overview of the entire medicines development and clinical trial processes, as well as the essential skills required to successfully manage clinical trials.
You will explore the lifecycle of medicines, from the initial stages of development through to the design and execution of clinical trials. Additionally, you’ll gain a clear understanding of the roles and responsibilities within clinical research, setting you up for success as a CRA.
✓ Understand the full spectrum of the medicines development process and its importance.
✓ Dive into the clinical development process, exploring each stage and its implications.
✓ Learn about clinical trial design and its critical role in ensuring valid and reliable study outcomes.
✓ Get familiar with the various roles and responsibilities within clinical trials, preparing you for a CRA career.
✓ Test your knowledge with a comprehensive knowledge check to ensure you’re ready to advance
- Lesson 1: Medicines Development Process
- Lesson 2: Clinical Development Process
- Lesson 3: Clinical Trial Design
- Lesson 4: Clinical Trial Roles and Responsibilities
- Knowledge Check
- Certificate: Purchase a Certificate for 34.90 EUR
Module 2: Data Management & Patient SafetyINTERMEDIATE
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
In this module, you’ll delve into the crucial aspects of patient safety within clinical research. As a Clinical Research Associate, safeguarding patient well-being is paramount. This module equips you with the knowledge and skills necessary to effectively manage investigational medicinal products, handle data with precision, and ensure rigorous patient protection throughout the clinical trial process.
You will also explore the identification and management of adverse events, ensuring that patient safety remains at the forefront of all clinical research activities.
✓ Gain expertise in the management of investigational medicinal products to ensure compliance and safety.
✓ Learn the fundamentals of data management and its importance in maintaining the integrity of clinical trials.
✓ Understand the essential principles of patient protection and how to implement them effectively in your role.
✓ Explore the process of identifying, reporting, and managing adverse events to safeguard patient well-being
✓ Test your knowledge with a comprehensive knowledge check to ensure you’re ready to advance.
- Lesson 5: Investigational Medicinal Product Management
- Lesson 6: Data Management for Clinical Research Associates
- Lesson 7: Patient Protection
- Lesson 8: Adverse Events
- Knowledge Check
- Certificate: Purchase a Certificate for 54.90 EUR
Module 3: Clinical Trial MonitoringINTERMEDIATE
6 lessons • 6 knowledge checks • virtual lab • certificate available to purchase
6 lessons • 6 knowledge checks • virtual lab • certificate available to purchase
This module provides an in-depth look at the critical responsibilities of Clinical Research Associates in monitoring clinical trial sites. As you progress through this module, you will develop the skills needed to effectively select, initiate, monitor, and close clinical trial sites, ensuring that each trial is conducted according to protocol and regulatory requirements.
In addition to traditional on-site monitoring, you will also explore the emerging practices of remote monitoring, gaining insights into the daily life of a remote monitor. This module equips you with the expertise needed to ensure the smooth operation and compliance of clinical trials.
✓ Learn the criteria and considerations for selecting optimal clinical trial sites
✓ Describe the rationale of complying with any given study protocol to protect patient rights and ensure data integrity.
✓ Gain proficiency in monitoring clinical trial sites to uphold the integrity of the trial and ensure adherence to protocol.
✓ Understand the processes involved in successfully closing clinical trial sites.
✓ Explore the principles and practices of remote monitoring, and understand the unique challenges and benefits it presents.
✓ Discover the daily responsibilities and best practices for remote monitors in the evolving landscape of clinical research.
- Lesson 9: Selecting Clinical Trial Sites
- Lesson 10: Initiating Clinical Trial Sites
- Lesson 11: Monitoring Clinical Trial Sites
- Lesson 12: Closing Clinical Trial Sites
- Lesson 13: Remote Monitoring Clinical Trial Sites
- Lesson 14: Daily Life of a Remote Monitor
- Knowledge Check
- Certificate: Purchase a Certificate for 74.90 EUR
Module 4: Clinical Research Regulatory Environment INTERMEDIATE
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
4 lessons • 4 knowledge checks • virtual lab • certificate available to purchase
This module focuses on the essential regulatory frameworks that every Clinical Research Associate must master. You will explore the ICH GCP E6(R3) guidelines, including the latest revisions and annexes, and understand how these principles apply to the conduct of clinical trials. This knowledge is critical for ensuring that trials are conducted ethically and in compliance with global standards.
Additionally, you will gain a thorough understanding of the regulatory environments in both the European Union and the United States, equipping you with the insights needed to navigate these complex landscapes effectively.
✓ Gain a deep understanding of the ICH GCP E6(R3) principles and how they guide clinical research practices.
✓ Explore the revisions in the ICH GCP E6(R3) ANNEX I and their implications for clinical trial conduct.
✓ Understand the ICH GCP E6(R3) appendices and how they support the implementation of Good Clinical Practice.
✓ Learn about the regulatory environments in the EU and USA, and how they impact clinical trials in these regions.
✓ Test your knowledge with a comprehensive knowledge check to ensure you’re ready to advance.
- Lesson 15: ICH GCP E6(R3) Principles
- Lesson 16: ICH GCP E6(R3) Revision ANNEX I
- Lesson 17: ICH GCP E6(R3) Appendices
- Lesson 18: Regulatory Environment in the EU & USA
- Knowledge Check
- Certificate: Purchase a Certificate for 74.90 EUR
Your Instructors:
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.
GABI DISSELHOFF
Gabriele has 40+ years of experience under her belt in pharmaceutical development, with 30+ years in pharmaceutical industry (Merck KGaA, Abbott) and 10+ years consulting. She has extensive industry experience in regulatory affairs, clinical research and clinical quality assurance, and a thorough knowledge of document management and electronic submissions.
Joanna Wilinska-Mackowiak
Joanna has dipped into many different aspects of clinical trials, most notably regulatory affairs and remote clinical data management. As such, she is very familiar with not only the regulatory aspects of clinical trials, and the requirements to monitoring, but has first-hand experience in both monitoring and remote monitoring, including the use of centralized statistical monitoring.
Andreas Beust
Andreas is the Chief Executive Officer of GCP-Service International, overseeing all work related to literature review, scientific and medical writing, as well as biostatistics. From education a biologist he started his career in clinical research as a data manager and biostatistician, establishing Centralized Statistical Monitoring services at GCP-Service and overseeing the integration into a risk-based monitoring approach.
Patricia Hollis
Patricia has been in the clinical research industry for 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.
KAMILA NOVAK
Kamila Novak, MSc, has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant in medical writing, auditing, training, project and risk management. She delivered dozens of courses in areas related to clinical research and project management. In August 2019, Kamila became a certified Lead Auditor for ISO 9001:2015. Kamila is a Core Team Member in the DIA GCP & QA, Clinical Research, and Project Management Communities.
BARTEK JAROSZ
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.
GAVIN CHAIT
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.
Katharina Zacher
Dr. Katharina Zacher-Aued is the team lead of the Clinical Document Management group at GCP-Service.
She is a biologist and worked in polar research for many years before starting her career in clinical research as a CRA and TMF Manager.
Together with her team, she established a risk-based document management approach for different types of clinical trials.
Alvi Vincent
Alvi Vincent is leading the TMF department overseeing the execution of studies related to TMF processes in compliance with quality standards and timeline metrics together with the team. She pursued two Master degrees in Applied Microbiology and Biomedical Immunology.
Certification Process:
Enrolment closes in
Online Self-paced
learn at your own schedule and pace
Real Life Cases – Virtual Lab
practice with real scenarios
Up-to-date & integrated
broad & relevant learning experience
Designed by Experts
120+ years industry know-how
What alumni say about this program
I would like to pass it but this days I’m so busy and I don’t have enough time to progress with it
The course is very detailed for its length and gives exactly what one may need to navigate the clinical research landscape and medical science.
VIARES is an amazing learning platform. After completing the Clinical Research Associate program, I feel well equipped to take on the role and responsibilities of a CRA with great confidence. I would definitely recommend it!
VIARES Micro Certificate PHASES OF CLINICAL TRIALS
VIARES Micro Certificate PHASES OF CLINICAL TRIALS
I have been doing the CRA course for about a month now and so far I am really enjoying it. The lectures are really easy to follow, interesting and informative. I'm looking forward to learning more.
I really enjoyed the course. The content was well condensed to what is really important.
The course is amazing journey into clinical research career attainment with deep insights of course units that are enriching ,from which knowledge and skills are drawn from , the course contents so far are rich and contributive to career progress.
very user friendly and lots of information to gather. Thank you
I want to say a big thank you to all VIARES Coordinators, for a well packaged program. It is so easy to understand a well-organized. I have just completed the Clinical Research Associate, it was awesome. I will recommend it to friends.
VIARES ACADEMY ALL-In-One
The CTA was very informative and had a wide topics covered. I am a fresher to the field but now with the knowledge imparted by all the professionals, I feel empowered, Thank you all. Looking forward to complete the other courses in the All in One Academy, Thank you Viares Team
So far my journey here to become a CRA has been so insightful and impactful. I look forward to more exciting topics and lectures as far as the CRA program is concerned.
Very informative yet user friendly
My only critique is with the navigation. When you finish one module it should have an arrow to go to menu of next module The course content is great and informative
What VIARES members get
Your membership to VIARES includes everything you need to excel in your clinical research career.
Worldwide LinkedIn community
Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.
Comprehensive Resource Library
Career center
Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.
Easy Learning Portal
Accredited Courses
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!
Job Support
With VIARES you also get support with finding your clinical research dream job.
Grow your career
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.
Why should I enroll in the VIARES CRA ACADEMY?
What are the typical responsibilities of a CRA?
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:
- Study site management: CRAs are often responsible for managing the study sites participating in a clinical trial. This may involve conducting site feasibility assessments, training site staff on study protocols and procedures, and monitoring site performance.
- Data collection and review: CRAs may collect and review study data to ensure that it is accurate and complete. This may involve reviewing medical records, lab reports, and other documentation.
- Adverse event monitoring: CRAs are responsible for monitoring adverse events reported by study participants and ensuring that they are reported and managed appropriately.
- Regulatory compliance: CRAs must ensure that the study is conducted in accordance with relevant regulations and guidelines, such as good clinical practice (GCP) and the International Conference on Harmonisation (ICH) guidelines.
- Documentation: CRAs must maintain accurate and complete study documentation, including case report forms (CRFs), study logs, and other study-related documents.
- Communication: CRAs must communicate effectively with study team members, site staff, and study participants to ensure that the study is conducted smoothly and that any issues are addressed in a timely manner.
- Subject recruitment: CRAs may be involved in supporting recruitment of eligible study participants.
Overall, the role of a CRA is multifaceted and requires a high level of attention to detail, organization, and communication skills.
What is the VIARES certificate?
Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the VIARES CRA ACADMEY , you get your personal 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.
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.
Is there a fixed schedule?
No, you can proceed with the course in your own pace.
Is this program the right fit for me?
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.
