283 reviews

Clinical Research Associate

Name: Clinical Research Associate
Price: 16.9 EUR
Availability: InStock
Rating: 4.89 (283 reviews)

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.

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?

✓ Globally accredited & industry recognized

✓ Join 9,000+ members worldwide

✓ Making you the best candidate for the job

✓ All the tools you need to level up your career

Read our 283 verified reviews

Program structure

Medicines Development Process, Good Clinical PracticeINTERMEDIATE
2 lessons • 1 assignment • 1 knowledge check • 8 hours

build a strong foundation in the clinical research field

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.

Welcome to your course
Lesson 1 - Microcourse: The Medicines Development Process
Lesson 2 - Microcourse: The Clinical Development Process
Assignment - Medicines Development and GCP
Knowledge Check - Medicines Development and GCP

Your instructor:

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.

Regulatory Environment in the EU and USAINTERMEDIATE
2 lessons • 1 assignment • 1 knowledge check • 8 hours

MASTER THE REGULATORY LANDSCAPE OF CLINICAL RESEARCH

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.

Lesson 1 - Microcourse: History and Development of Regulatory Requirements in the EU and USA
Lesson 2 - Microcourse: Regulated Activities in Clinical Research in the EU and USA
Assignment - Regulatory Environment in the EU and USA
Knowledge Check - Regulatory Requirements, Compliance and Quality Assurance, Audits and Inspections

Your instructor:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Clinical Trial Design & Clinical Research Roles and ResponsibilitiesINTERMEDIATE
2 lessons • 1 assignment • 1 knowledge check • 9 hours

DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

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.

Lesson 1 - Microcourse: The Study Protocol
Lesson 2 - Microcourse: Clinical Research Roles and Responsibilities
Assignment - Clinical Trial Design & Clinical Research Roles and Responsibilities
Knowledge Check - Clinical Trial Design & Clinical Research Roles and Responsibilities

Your instructor:

KHILNA SAMAT

Selecting and Initiating Clinical Trial Sites INTERMEDIATE
3 lessons • 1 assignment • 1 knowledge check • 8 hours

EFFECTIVELY SELECT AND INITIATE CLINICAL TRIAL SITES

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.

Lesson 1 - Microcourse: The Role of a CRA
Lesson 2 - Microcourse: Site Selection
Lesson 3 - Microcourse: Site Preparation and Initiation
Assignment - Selecting and Initiating Clinical Trial Sites
Knowledge Check - Selecting and Initiating Clinical Trial Sites

Your instructor:

KHILNA SAMAT

Monitoring and Closing Clinical Trial Sites INTERMEDIATE
2 lessons • 1 assignment • 1 knowledge check • 8 hours

ENSURE EFFECTIVE MONITORING AND CLOSURE OF CLINICAL TRIAL SITES

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.

Your instructor:

KHILNA SAMAT

Patient Protection & Adverse Events INTERMEDIATE
2 lessons • 1 assignment • 1 knowledge check • 8 hours

ENSURE PATIENT SAFETY AND MANAGE ADVERSE EVENTS

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.

Your instructor:

KHILNA SAMAT

Investigational Medicinal Product Management INTERMEDIATE
1 lesson • 1 assignment • 1 knowledge check • 8 hours

MASTER THE MANAGEMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS

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.

Your instructor:

KHILNA SAMAT

Data Management for Clinical Research AssociatesINTERMEDIATE
4 lessons • 1 assignment • 1 knowledge check • 8 hours

MASTER DATA MANAGEMENT IN CLINICAL RESEARCH

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.

Lesson 1 - Microcourse: Introduction - Data Management for CRAs
Lesson 2 - Microcourse: Data Management for CRA Part 1
Lesson 3 - Microcourse: Data Management for CRA Part 2
Lesson 4 - Microcourse: Data Management for CRA Part 3
Assignment - Data Management for Clinical Research Associates
Knowledge Check - Data Management for Clinical Research Associates

Your instructor:

GAVIN CHAIT

Data Scientist at Whythawk

Certification Exam
Exam • 2 hours

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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Duration: 80 hours

Study 3 hours a week to finish in 6 months

8 modules + official certificate

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Lifetime Access
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Life-time access to the Clinical Research Associate course

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Including Clinical Research Career Accelerator
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Access to the Clinical Research Virtual Lab for practical experience
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STANDARD

4.89 based on 283 reviews

5 Day Money-back Guarantee!

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.

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

Access a vast collection of templates, tools, and playbooks to enhance your clinical research work.

Career center

Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.

Easy Learning Portal

Enjoy a user-friendly platform that makes accessing course materials and resources straightforward and convenient.

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.

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FAQ

Need help making the right choice?

Send our admissions advisors a message.

Why should I enrol in this Clinical Research Associate course?

Enrolling in this Clinical Research Associate (CRA) course allows you to contribute to medical advancements by participating in clinical trials that test new drugs and devices, improving patient lives. The field offers substantial career growth potential, with high demand for skilled CRAs leading to opportunities for advancement and increased earnings. The role also provides flexibility, allowing you to work for various employers, including pharmaceutical companies and academic institutions, or remotely with travel opportunities. Additionally, it offers personal fulfillment by playing a crucial role in enhancing patient outcomes.

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 course and your exam, you get your personal “Course 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. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).

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.

What alumni say about this program

Excellent...Game-changer!!!

The Viares CRA course has been an incredible boost to my career in Clinical Research. The practical knowledge, expert guidance, and real-world insights have truly set me up for success in this field. I highly recommend this course to anyone looking to grow in Clinical Research!"

Overall, I found the CRA course to be informative and well-organized. The course covered important topics such as GCP guidelines, clinical trial processes, data management, and regulatory requirements. The content was detailed, organized, and suited for an online learning environment. I appreciated the use of real-world examples to illustrate complex topics.

Excellent

Excellent

The content of the course is very informative and insightful...I WILL LOVE TO TAKE THE Start up specialist soon.I will highly recommend it to my colleagues.

VIARES Micro Certificate PHASES OF CLINICAL TRIALS

Clinical Operations Specialist

This was an incredible course that provided important insight to the operational aspects of the regulatory process.

Clinical Study Coordinator I

Clinical Research Associate

VIARES Clinical Research Associate Academy

N/A

Medicine development process and the Regulatory requirements compliance and Quality Assurance Audits and Inspection.

Clinical Research Associate

The 'All in One' order process was easy, accessing materials is straightforward, and content is informative. On-demand access is very convenient for completion.

Clinical trial assistant

I would like to pass it but this days I’m so busy and I don’t have enough time to progress with it

Exceptional

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 Micro Certificate DATA ANALYSIS

Very informative

Detailed information

Clinical Research Associate Academy

Great learning platform

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

Clinical Research Associate

Great

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.

Clinical Trials Assistant Academy

Very Good

I really enjoyed the course. The content was well condensed to what is really important.

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Clinical Research Associate

What you will learn

Why VIARES?

Program structure

build a strong foundation in the clinical research field

Your instructor:

MASTER THE REGULATORY LANDSCAPE OF CLINICAL RESEARCH

Your instructor:

DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

Your instructor:

EFFECTIVELY SELECT AND INITIATE CLINICAL TRIAL SITES

Your instructor:

ENSURE EFFECTIVE MONITORING AND CLOSURE OF CLINICAL TRIAL SITES

Your instructor:

ENSURE PATIENT SAFETY AND MANAGE ADVERSE EVENTS

Your instructor:

MASTER THE MANAGEMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS

Your instructor:

MASTER DATA MANAGEMENT IN CLINICAL RESEARCH

Your instructor:

Get free access to our learning portal and experience it yourself

Enrollment Closes In:

Lifetime Access 1 payment

1 Year Access 1 payment

1 Year Access 12 installment payments

5 Day Money-back Guarantee!

What VIARES members get

Worldwide LinkedIn community

Comprehensive Resource Library

Career center

Easy Learning Portal

Accredited Courses

Job Support

Grow your career

FAQ

What alumni say about this program

Related Clinical Research Programs

VIARES ACADEMY ALL-In-One

Clinical Research Project Manager Academy

Clinical Study Coordinator I

Study Start Up Specialist

Trial Master File Specialist

Clinical Operations Specialist

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Lifetime Access
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