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.
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.
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.
Develop expertise in tracking participant compliance, managing investigational product logistics, and understanding protocol deviations and corrective action plans.
Acquire advanced knowledge in regulatory binder management, ensuring accurate documentation, and compliance with all clinical trial regulations and ethical standards.
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.
Patricia Hollis
in the industry for 21 years
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.
Patricia Hollis
in the industry for 21 years
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.
Patricia Hollis
in the industry for 21 years
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
Patricia Hollis
in the industry for 21 years
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.
Patricia Hollis
in the industry for 21 years
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.
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.
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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.
There are several reasons why you might consider becoming an advanced clinical study coordinator:
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:
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:
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 Study Coordinator III
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Verified ownerJust finished the VIARES CRA Academy and I’m blown away. Clear, practical, straight-to-the-point lessons that actually prepare you for the real job. Passed the exam first try. Best investment I’ve made in my career. Highly recommend!
Thank you VIARES
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
