Clinical Study Coordinator I – Enterprise

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 Study Coordinator or similar.

COURSE Content

Successfully complete the 8 competency modules below to obtain your VIARES Clinical Study Coordinator Certificate.

Introduction to Clinical Research

Historical events that shaped today’s research platform.
- Nuremberg Code (1947)
- Declaration of Helsinki (1964)
- Belmont Report Principles (1979)
- National Research Act (1974)
- International Standard Organization 14155

ICH/GCP and CFR 21

A global response to unethical research
International Council of Harmonisation and Good Clinical Practice Guidelines (ICH/GCP)
14 principles of GCP
Food and Drug Administration (FDA)

Clinical Research Process and Study Design

Clinical Research Process
Study Designs in Clinical Trials
- Randomization
- Non-Randomization
Phases of clinical research
- Pre-Clinical
- Phases I-IV

Clinical Research Organizations, Vendors, Ethic Boards and Sites

Understand Clinical Research organizational char
- Clinical Site Organizations
- Site Management Organizations
- Vendors
- Sites
- Pharmaceuticals/Biopharma
- Institutional Review Board/IEC

Study Coordinator and Site Staff

Investigators
Supplemental research staff
Documentation requirements for assigned task
CRCs responsibility for managing site staff training and delegation log
Delegation Log

Protocol and Informed Consent Form (ICF)

Clinical Research Protocol
Informed Consent Form (ICF)
Source Documents
Medical Records
Standard of Operations

Medical History, Adverse Events/Serious Adverse Events and Concomitant Medication

Adverse Events
Serious Adverse Events
Concomitant Medication (ConMed)
Medical History-out

The Monitor

Monitor Role
Visits
- Selection
- Initiation
- Interim
- Close Out
- Booster
Communication
Query Resolution
Identifying and resolving site issues

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.

Getting a clinical study coordinator certification can be a valuable step in advancing your career and demonstrating your expertise in the field. Here are a few potential reasons why you may want to consider pursuing certification:

Enhancing your credentials: A clinical study coordinator certification can demonstrate to employers, colleagues, and patients that you have met certain professional standards and have a certain level of expertise in your field. This can be particularly important in a field as highly regulated as clinical research.
Improving your job prospects: Having a certification can make you a more competitive job candidate and can help you stand out in a crowded job market. Some employers may even require or prefer that their clinical study coordinators have certification.
Continuing education and professional development: Many certification programs require ongoing education and training to maintain the certification. This can be a way to stay up-to-date with the latest developments in the field and to continue developing your skills and knowledge.
Increased salary potential: Having a clinical study coordinator certification can potentially lead to higher earning potential as it demonstrates your level of expertise and professionalism.

Overall, getting a clinical study coordinator certification can be a valuable investment in your career and can help you demonstrate your commitment to excellence in the field of clinical research.

Hear from our graduates

Jodie

I found the VIARES Study Start Up Specialist program extremely informative and educational. Not only has my understanding of study start up developed exponentially, but it has also made me feel so much more confident in my work. I’d highly

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recommend the program to anyone who wishes to learn more about study start up!

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Magda

The Viares Clinical Research Academy Talent Program was an exceptional experience! I would never think that online learning can be so well developed and structured. As a person with no monitoring experience, the Academy helped me to

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understand and also built my confidence in the Clinical Research. I feel well prepared to get my first job in this field. Many thanks to Dietmar Eglhofer, the whole team and all amazing tutors who made this program so professional. It was a great opportunity to gain new knowledge and I would recommend it to anyone interested in the field of clinical trials.

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reviews curated by judge.me

WHY BECOME A CLINICAL STUDY COORDINAOR?

Becoming a clinical study coordinator can be a rewarding career path for a number of reasons. Here are a few potential reasons why you may want to consider this profession:

Contributing to the advancement of medical research: As a clinical study coordinator, you would be involved in the planning, coordination, and execution of clinical trials and other medical research studies. This can be an opportunity to contribute to the development of new treatments and therapies that could improve the lives of patients.
Working in a dynamic and challenging field: Clinical research is a constantly evolving field, and as a study coordinator, you would be at the forefront of this work. You would be responsible for ensuring that studies are conducted in compliance with regulatory requirements and ethical standards, and you would need to stay up-to-date with the latest developments in the field.
Building a diverse skillset: As a study coordinator, you would gain a variety of skills that could be valuable in other areas of healthcare or research. These could include project management, data analysis, communication, and problem-solving.
Making a difference for patients: Ultimately, the work of a clinical study coordinator is about improving patient care. By helping to facilitate studies that could lead to new treatments or better understanding of disease, you could have a significant impact on the lives of patients and their families.
Strong compensation: The salary of a clinical study coordinator can vary depending on a number of factors, including location, years of experience, and the specific industry or organization in which they work. According to the U.S. Bureau of Labor Statistics (BLS), the median annual wage for clinical research coordinators in the United States was $51,510 as of May 2020. However, salaries can range from around $32,000 to over $83,000 per year. It’s worth noting that salaries may also be higher for study coordinators with advanced degrees or specialized expertise in certain areas of research.

Of course, becoming a study coordinator also requires hard work, attention to detail, and a commitment to accuracy and compliance. But if you are passionate about medical research and helping others, it could be a rewarding and fulfilling career choice.

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Study Coordinator?

The responsibilities of a clinical study coordinator can vary depending on the specific study or trial they are working on, as well as the organization or institution they are employed by. However, some typical responsibilities of a clinical study coordinator may include:

Planning and coordinating the study: Clinical study coordinators are responsible for helping to design and plan the study, including determining the research question, identifying study participants, and deciding on study protocols and procedures.
Obtaining informed consent: Study coordinators must ensure that study participants understand the risks and benefits of participation and that they have given their informed consent to be part of the study.
Managing study documents: Study coordinators maintain all necessary documentation for the study, including regulatory submissions, study protocols, and participant consent forms.
Collecting and analyzing data: Clinical study coordinators are responsible for collecting data from participants and ensuring that it is recorded accurately and securely. They may also be responsible for analyzing the data and reporting on the findings.
Ensuring compliance with regulations and ethical standards: Study coordinators must ensure that the study is conducted in compliance with all applicable regulations and ethical standards, including those related to patient privacy and confidentiality.
Communicating with study participants and other stakeholders: Clinical study coordinators may communicate with study participants to answer questions and provide updates, as well as with other stakeholders such as study sponsors, principal investigators, and regulatory agencies.
Managing study finances: Study coordinators may be responsible for managing study finances, including tracking expenses and ensuring that the study stays within budget.

Overall, the role of a clinical study coordinator is critical to the success of any medical research study or clinical trial. By ensuring that the study is conducted ethically and according to regulatory requirements, and that data is collected accurately and securely, study coordinators help to advance our understanding of disease and improve patient care.

IS THIS THE BEST OPTION FOR ME?

The specific educational and professional background required to become a clinical study coordinator can vary depending on the employer and the specific job requirements. However, most employers prefer or require candidates to have a bachelor’s degree in a related field such as nursing, biology, life sciences, or a health-related field. Some employers may also prefer or require candidates to have a graduate degree such as a master’s degree in a related field.

In addition to education, employers typically look for candidates with relevant experience in the field of clinical research or healthcare. Clinical experience, such as experience as a nurse or medical assistant, may also be valuable.

Other important qualifications for a clinical study coordinator may include:

Strong organizational and communication skills
Attention to detail and the ability to accurately collect and record data
Knowledge of good clinical practice (GCP) guidelines and regulations governing clinical research
Proficiency in relevant computer software and electronic data capture systems
Ability to work independently and as part of a team

Overall, a background in a related field, such as healthcare or life sciences, combined with relevant experience and key qualifications can prepare you to become a successful clinical study coordinator.

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 research online course - clinical study coordinator

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Clinical Study Coordinator I – Enterprise

€ 239,90

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€ 239,90

Clinical Study Coordinator I – Enterprise

COURSE Content

VIARES CERTIFICATE

Hear from our graduates

Jodie

Magda

WHY BECOME A CLINICAL STUDY COORDINAOR?

WHAT ARE TYPICAL RESPONSIBILITIES OF A Clinical Study Coordinator?

IS THIS THE BEST OPTION FOR ME?

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