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Clinical Study Coordinator II

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

What you will learn

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Gain a comprehensive understanding of ALCOA-CCEa principles and the proper handling of source documents in clinical research.

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Learn essential procedures for managing informed consent, medical histories, and concomitant medications, ensuring compliance with regulatory standards.

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Develop skills in evaluating inclusion/exclusion criteria, confirming subject eligibility, and managing adverse events and protocol deviations.

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Master techniques for accurate documentation and data reconciliation, ensuring high standards of data quality and integrity throughout the clinical trial process.

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

ALCOA-CCEa and Source DocumentsPROFESSIONAL
1 lesson • 1 assignment • 1 knowledge check • 9-10 hours
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MASTER ACCURATE SOURCE DOCUMENTATION

This comprehensive module focuses on the critical aspects of source documentation in clinical research. You will delve into the ALCOA-CCEa principles, which ensure data integrity and reliability in clinical trials. By the end of this module, you’ll be adept at managing and completing various types of source documents according to industry standards, ensuring precision and compliance in your research documentation.

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

Understand various forms of source documents used in clinical trials.

Learn the basic principles of completing clinical research source documents.

Master the principles of source documentation in clinical research.

Be able to complete source documents in clinical research utilizing industry standards.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER THE ESSENTIALS OF CLINICAL RESEARCH

This module is designed to provide you with a comprehensive understanding of the informed consent process, ensuring you can conduct clinical research with the highest ethical standards. You will learn to execute informed consent forms (ICFs) correctly and understand their critical elements. Additionally, you will become proficient in taking accurate medical histories and managing concomitant medications, essential for maintaining high standards of patient care 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 informed consent process and its importance in clinical research.

Learn the elements of an ICF and how to relate them to the subject

Know how to elicit medical history from a potential subject and how to complete a Medical History log.

Understand what ConMeds are and how to complete a ConMeds log.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER THE BASELINE VISIT PROCESS IN CLINICAL RESEARCH

This module will equip you with the essential knowledge and skills to conduct a successful baseline visit in clinical research. You’ll delve into the specifics of learning elements, schedule of events, and source documents. Additionally, you’ll master the intricacies of inclusion/exclusion criteria, eligibility, and the importance of conmeds and medical history documentation. With the guidance of expert instructor Patricia Hollis, you’ll gain the competence needed to ensure a seamless and compliant baseline visit.

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

Learn the meaning of Inclusion/Exclusion criteria and the vital process of confirming Eligibility for a subject during a baseline visit.

Understand the importance of Eligibility confirmation and requirements.

Learn how to update Medical History and ConMeds log and document visit data.

Be able to determine when a subject has screen failed and follow-up procedures.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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EXCEL IN CLINICAL RESEARCH DOCUMENTATION AND EVENT MANAGEMENT

This module will equip you with the necessary skills to meticulously document clinical research visits and manage adverse events efficiently. You will delve into source documentation, medical history, and the reconciliation of concomitant medications (ConMeds) and adverse events (AEs). By mastering these skills, you’ll enhance the accuracy and reliability of your clinical research data.

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

Learn definitions of Serious Adverse Events (SAEs) and Adverse Events (AEs).

Identify and process adverse events effectively.

Reconcile ConMeds, AE, and Medical History logs with precision.

Understand the importance of accurate source documentation.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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ACHIEVE EXCELLENCE IN CANCER TREATMENT RESEARCH

This module is designed for professionals aiming to excel in cancer treatment research. You will delve into advanced methodologies, protocols, and regulatory requirements specific to oncology clinical trials. With a focus on the latest advancements and best practices, this module ensures you are well-equipped to conduct high-quality research that can contribute to life-saving treatments.

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

Understand the intricacies of cancer treatment protocols and patient management.

Learn to document and report adverse events and new concomitant medications effectively.

Identify and manage protocol deviations with precision.

Master the concept of verifiable data in clinical research.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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OPTIMIZE YOUR CLINICAL RESEARCH SKILLS

This module will equip you with essential skills for managing the Day 7 Visit in clinical trials. You’ll delve into crucial procedures, from documenting new Adverse Events (AEs) and Concomitant Medications (ConMeds) to identifying and recording protocol deviations. Enhance your ability to gather verifiable data and ensure compliance with study protocols through hands-on assignments and knowledge checks.

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

Elicit and update subject’s health information.

Document new AE and ConMeds accurately.

Identify and appropriately document protocol deviations.

Understand the concept of verifiable data for reliable results.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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ACHIEVE EXCELLENCE IN CLINICAL RESEARCH

In this module, you will delve into the critical aspects of a Day 14 visit in clinical research. You will learn to meticulously document and reconcile medical history, adverse events, and concomitant medications. By understanding and identifying protocol deviations, you will ensure data integrity and patient safety. This module provides the expertise needed to excel in clinical assessments and documentation.

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

Elicit and update subject’s health information.

Document new AE and ConMeds accurately.

Identify and document protocol deviations effectively.

Understand the concept of verifiable data.

Your instructor:

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Patricia Hollis

in the industry for 21 years

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MASTER THE MONITORING PROCESS IN CLINICAL RESEARCH

This module is designed to provide you with comprehensive knowledge and practical skills for conducting and documenting a Day 28 Visit in clinical research. You’ll delve into the key procedures and tasks, including eliciting and updating subject health information, documenting new adverse events (AEs) and concomitant medications (ConMeds), and identifying and documenting protocol deviations. Through this module, you’ll gain a thorough understanding of verifiable data and its importance in clinical research.

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

Understand the procedures for a Day 28 visit in clinical trials.

Learn how to elicit and update subject health information.

Document new adverse events (AEs) and concomitant medications (ConMeds).

Identify and appropriately document protocol deviations.

Master the concept of verifiable data and its significance in clinical research.

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
8 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 II course
Original price was: € 39,90.Current price is: € 19,90.

monthly for 6 months

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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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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
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(237)
5%
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2%
(6)
0%
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(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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