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Clinical Study Coordinator III

On successful completion of this program, you will be certified and will have acquired advanced knowledge, skills and competencies to push your career as Clinical Study Coordinator.

What you will learn

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Gain a comprehensive understanding of the role and responsibilities of a Clinical Study Coordinator, including managing Institutional Review Boards (IRBs), regulatory compliance, and clinical trial documentation.

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Master the skills needed for maintaining regulatory and training logs, handling FDA forms, and managing investigational products to ensure the highest standards of clinical trial conduct.

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Develop expertise in tracking participant compliance, managing investigational product logistics, and understanding protocol deviations and corrective action plans.

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Acquire advanced knowledge in regulatory binder management, ensuring accurate documentation, and compliance with all clinical trial regulations and ethical standards.

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

Program structure

Institutional Review Board (IRB)PROFESSIONAL
1 lesson • 1 assignment • 1 knowledge check • 12 hours
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ADVANCE YOUR CLINICAL RESEARCH EXPERTISE

This module delves into the critical role of the Institutional Review Board (IRB) in clinical research. You’ll gain a comprehensive understanding of the IRB’s purpose, responsibilities, and processes. This module is designed to ensure you can effectively navigate the ethical and regulatory landscape of clinical studies.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the purpose of an IRB.

Describe the three types of reviews.

Understand board composition requirements.

Differentiate between Local and Central IRB.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER THE ESSENTIALS OF REGULATORY COMPLIANCE

This comprehensive module equips you with the knowledge and skills to handle regulatory requirements effectively in clinical research. You’ll delve into the critical aspects of managing facilities, equipment, and logs, ensuring compliance with industry standards. Additionally, you’ll learn how to maintain accurate delegation and training logs to support regulatory inspections and audits.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Complete a delegation log with precision and accuracy.

Understand the regulatory requirements of a delegation log and their implications.

Successfully complete a training log to maintain compliance.

Learn the correlation between delegation and training requirements to ensure regulatory adherence.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER REGULATORY DOCUMENTATION IN CLINICAL RESEARCH

This advanced module is designed to provide in-depth knowledge of essential regulatory documents required in clinical research. You’ll delve into the specifics of tracking logs, FDA forms, and the investigator’s brochure, ensuring you have the skills to manage and complete these critical documents accurately.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the components of a regulatory binder and their importance.

Learn how to accurately complete Informed Consent and Subject logs.

Gain proficiency in filling out FDA forms 1572 and 3455.

Explore the contents and significance of an Investigator’s Brochure.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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DISCOVER THE ESSENTIALS OF INVESTIGATIONAL PRODUCT MANAGEMENT

Dive into the intricacies of managing investigational products (IP) in clinical research. This module provides a comprehensive understanding of IP, covering everything from its description and handling to regulatory requirements. With expert guidance from Patricia Hollis, you’ll be well-equipped to ensure compliance and accuracy in all aspects of IP management.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Describe Investigational Product

Know the Principal Investigator’s responsibility

Understand Non-Medicinal Products

Discuss the IP shipping, dosing, and destruction process

Calculate subject compliance IP and dose

Complete IP accountability log

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTERING PROTOCOL DEVIATIONS IN CLINICAL RESEARCH

This module is designed to equip you with the necessary skills to handle protocol deviations effectively within clinical research. You will delve into the definitions and documentation required for protocol deviations, learn about corrective actions and preventative actions (CAPA), and master techniques like the 5 Whys and Root Cause Analysis. This comprehensive approach ensures you are well-prepared to manage and mitigate deviations in clinical protocols.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the definition and documentation of protocol deviations.
Distinguish between major and non-major protocol deviations.
Learn the 5 Whys methodology and how to create a CAPA.
Conduct effective Root Cause Analysis.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER THE ESSENTIALS OF REGULATORY DOCUMENTATION

In this comprehensive module, you will delve into the crucial aspects of maintaining a regulatory binder in clinical research. The focus will be on understanding, organizing, and managing essential documents that ensure compliance and facilitate smooth clinical trial operations. By mastering these skills, you will enhance the efficiency and accuracy of your research processes.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the concept of the regulatory binder and its importance in clinical trials.
Identify and manage the various document types included in a regulatory binder.
Organize general, subject, laboratory, investigational product, financial, and monitoring visit documents effectively.
Learn best practices for maintaining and updating the regulatory binder.
Prepare for regulatory inspections and audits with confidence.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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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Online Self-paced
learn at your own schedule and pace

Duration: 80 hours
Study 3 hours a week to finish in 6 months
6 modules + official certificate
testing through quizzes + exams

Get free access to our learning portal and experience it yourself

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You can test your knowledge with our free micro-certificates, that cover some of the most important topics in clinical research.
This way you can test the learning environment before buying!

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Single

6 months access to the Clinical Study Coordinator III course
Original price was: € 39,90.Current price is: € 19,90.

monthly for 6 months

1 Certificate Program

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Original price was: € 399,90.Current price is: € 199,90.

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All in One

Life-time access to all of our courses to elevate your clinical research career.

Original price was: € 499,90.Current price is: € 299,90.

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15 Certificate Programs

4.89 based on 257 reviews

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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.

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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.
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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.
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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!

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Job Support

With VIARES you also get support with finding your clinical research dream job.

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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.

Study Start Up Specialist online course clinical research
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SUPPORT

FAQ

Need help making the right choice?

Send our admissions advisors a message.

There are several reasons why you might consider becoming an advanced clinical study coordinator:

  • Impact on patient health: As an advanced clinical study coordinator, you would play a critical role in helping to bring new treatments and therapies to patients. By coordinating clinical trials, you would be contributing to the development of potentially life-saving treatments and helping to improve the quality of life for patients.
  • Career growth and advancement: As an advanced clinical study coordinator, you would have the opportunity to take on more complex and challenging studies, work with a wider range of stakeholders, and develop new skills and expertise. This could lead to career advancement opportunities, such as becoming a project manager or clinical research associate.
  • Job security: The demand for skilled clinical study coordinators is high, and this is likely to continue as the pharmaceutical industry grows. This means that there is likely to be job security and opportunities for career advancement in this field.
  • Competitive salary: Advanced clinical study coordinators are typically well-compensated, with salaries that are competitive with other healthcare professions. The salary of an advanced clinical study coordinator can vary depending on a number of factors, such as the location, level of experience, industry, and employer. According to data from the Bureau of Labor Statistics (BLS), the median annual wage for clinical research coordinators, which includes advanced clinical study coordinators, was $53,000 as of May 2020 in the United States. However, salaries can range from around $40,000 to over $80,000 per year, with many coordinators earning in the range of $50,000 to $70,000. Experienced coordinators, those with advanced degrees, or those working in the pharmaceutical industry may earn higher salaries. Overall, the salary of an advanced clinical study coordinator can be competitive, with potential for growth and higher compensation over time as you gain more experience and responsibility.
  • Flexibility: Many clinical study coordinators work in a variety of settings, including hospitals, research institutions, and pharmaceutical companies. This means that there may be opportunities to work in a setting that is convenient and fits your lifestyle.

 

Overall, becoming an advanced clinical study coordinator can be a rewarding and fulfilling career path with opportunities for growth, job security, and competitive compensation.

The responsibilities of an advanced clinical study coordinator can vary depending on the organization and the specific clinical trial or study they are working on. However, here are some typical responsibilities you might expect in this role:

  • Participant recruitment and enrollment: Developing and implementing strategies to recruit and enroll study participants, including advertising, outreach, and communication with potential participants.
  • Data collection and management: Overseeing the collection and management of study data, including ensuring that data is accurate, complete, and entered into study databases in a timely manner.
  • Participant communication: Communicating with study participants to provide information about the study, answer questions, and ensure that they are fully informed and comfortable with the study procedures.
  • Compliance and regulatory oversight: Ensuring that all study procedures are conducted in compliance with regulatory requirements and ethical guidelines, including obtaining informed consent from participants and reporting adverse events.
  • Study coordination: Coordinating study activities with other members of the study team, including principal investigators, research nurses, and other study coordinators.
  • Budget and resource management: Managing the study budget and resources, including tracking expenses, coordinating with vendors, and ensuring that the study is conducted within budget.
  • Quality control and assurance: Conducting regular quality control checks to ensure that the study is conducted according to protocol, and implementing corrective action as needed.
  • Documentation and reporting: Preparing study reports, including progress reports, safety reports, and final study reports, and ensuring that all documentation is complete and accurate.

 

Overall, the role of an advanced clinical study coordinator is to manage and coordinate all aspects of clinical studies, from study planning and design to study closeout. Effective coordination and communication with all stakeholders involved in the study, including study participants, principal investigators, and regulatory agencies, is essential to ensure the success of the study.

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.

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.

What alumni say about this program

Based on 257 reviews
92%
(237)
5%
(13)
2%
(6)
0%
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0%
(1)

VIARES ACADEMY ALL-In-One

Excellent

Clinical Research Associate

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 informative

very user friendly and lots of information to gather. Thank you

Clinical Study Coordinator Academy

Course content

Very rich course content.

Excellent

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.

C
VIARES ACADEMY ALL-In-One
Ciprian Matcovici

VIARES ACADEMY ALL-In-One

Fabulous and super powered

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

A
Clinical Research Associate Academy
Anthony Abudu
VIARES ASSESSMENT REVIEW

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.

V
VIARES ACADEMY ALL-In-One
Vincent Alushula
Straight forward course

Very informative yet user friendly

Great information

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

N
Clinical Trials Assistant Academy
Nhlamulo Wendy Baloyi

Clinical Trials Assistant Academy

Trial Master File Specialist

I want to say a big thank you to all the instructors and VIARES Academy for the great privilege to this unique ,easy to understand and accessible program. You'll have contributed immensely to my life. Good job

M
VIARES ACADEMY ALL-In-One
Maria Vilas Eiroa

VIARES ACADEMY ALL-In-One

Insightful

Alot of content relevant to my area of work.

R
Clinical Research Associate Academy
Regina Akise

Clinical Research Associate Academy

Excellent

This is awesome experience for me, the course outline is so easy to understand. Thank you Viares and all the lecturers, you all did a fantastic job. The course is 100% relevant.

N
Clinical Research Associate Academy
Nasson Chibwana
Very informative

The course structure is very simple to follow and above all the topics are taught by experts in the field.

Clinical Trials Assistant Academy

V
Clinical Research Associate Academy
Vincent Alushula
Mr Vincent

Awesome Self explanatory course. User friendly and easy to navigate and work it out. A love the fact that it keeps tabs with previous topic location.

Excellent

Excellent value for money

So far this has been a great purchase. I have completed two of the courses and am working on a third.

K
VIARES ACADEMY ALL-In-One
Karima Oumalk

VIARES ACADEMY ALL-In-One

Excellent CRA course

It is well explained and easy to understand , It opened my eyes to the highly new research world.

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