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Clinical Study Coordinator Academy

On successful completion of this Academy, you will be certified and will have acquired knowledge, skills and competencies to start as Clinical Study Coordinator or similar.

Courses included: Clinical Study Coordinator I – Clinical Study Coordinator II – Clinical Study Coordinator III

Listen what you can learn in this course:

THE CSC ACADEMY PROVIDES YOU WITH

Industry required competencies for many starting roles including

    • introduction to clinical research
    • ICH/GCP and CFR 21
    • Documentation requirements for assigned task
    • CRCs responsibility for managing site staff training and delegation log
    • Delegation Log
    • Clinical Research Protocol
    • Informed Consent Process and Form (ICF)
    • ALCOA-CCEA Principles
    • Medical History
    • Institutional Review Board
    • Form FDA 1572, Form FDA 3455
    • Source Documentation
    • Corrective Action Preventative Action (CAPA)
    • and much more
 

A proven process to prepare your job application

    • identify your dream job
    • understand what are the requirements and how to meet them
    • create a clear and concise CV
    • prepare your interview
    • negotiate your package
 

You can start your program any time after purchase and define your own pace with our online setup.

ACADEMY CONTENT

Clinical Study Coordinator I

  • 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
  • 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
  • Study Designs in Clinical Trials
    • Randomization
    • Non-Randomization
  • Phases of clinical research
    • Pre-Clinical
    • Phases I-IV
  • Understand Clinical Research organizational char
    • Clinical Site Organizations
    • Site Management Organizations
    • Vendors
    • Sites
    • Pharmaceuticals/Biopharma
    • Institutional Review Board/IEC
  • Investigators
  • Supplemental research staff
  • Documentation requirements for assigned task
  • CRCs responsibility for managing site staff training and delegation log
  • Delegation Log
  • Clinical Research Protocol
  • Informed Consent Form (ICF)
  • Source Documents
  • Medical Records
  • Standard of Operations
  • Adverse Events
  • Serious Adverse Events
  • Concomitant Medication (ConMed)
  • Medical History-out
  • Monitor Role
  • Visits
    • Selection
    • Initiation
    • Interim
    • Close Out
    • Booster
  • Communication
  • Query Resolution
  • Identifying and resolving site issues

Clinical Study Coordinator II

  • ALCOA-CCEA Principles
  • Source DocumentsTypes
  • Correction Methods
  • Schedule of Events
  • Informed Consent Form (ICF)
  • Informed Consent Process
  • Elements of an ICF
  • Medical History
  • Source Documentation
  • Concomitant Medication (ConMeds
  • Schedule of Events
  • Source Documents
  • Inclusion/Exclusion Criteria
  • Eligibility
  • ConMeds
  • Medical History
  • Source Documentation
  • ConMeds
  • Medical History
  • Adverse Events (AE) and Serious Adverse Events
  • Day 3 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 7 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 14 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations
  • Day 28 procedures
  • New AE/ConMeds
  • Medical History/AE/ConMeds reconciliation
  • Protocol Deviations

Clinical Study Coordinator III

  • Institutional Review Board
  • Role Responsibilities
  • Composition
  • Review Process
  • Documents
  • Facilities
  • Equipment
    • Calibration
    • Temperature
  • Logs
    • Delegation Log
    • Training Log
  • Inform Consent Log
  • Subject Logs
    • Identification Log
    • Enrollment Log
  • FDA Documents
    • Form FDA 1572
    • Form FDA 3455
  • Investigator’s Brochure
  • Investigational Product (IP)
  • Non-Investigational Medicinal Products
  • IP Maintenance
    • Receiving
    • Storage
    • Temperature
  • IP Accountability Log
  • Subject Compliance
  • Regulatory documents
  • Protocol Deviations (PD)
    • Definition
    • Documentation
  • Note-To-File
  • Corrective Action Preventative Action (CAPA)
  • The 5 Whys
  • Root Cause Analysis

Application support program

included with one-time payment plan

  • Setting clear goals and expectations is the crucial first step when it comes to your job search.
  • Understand WHAT are the required skills of your dream job and how to acquire them 
  • you will address THE most important piece to get your dream job
  • As often, it’s more about preparation and practice than any other “miracle tip”. There is no secret – however, there is a good way to prepare correctly for any interview (a method), and this method works well.
  • Negotiate and Get What You Truly Deserve.

3 VIARES CERTIFICATEs

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the program and your exams, you get 3 (Clinical Study Coordinator I, Clinical Study Coordinator II, Clinical Study Coordinator III) personal certificates 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.

Delivered by industry experts

PATRICIA HOLLIS

Clinical Operations Expert

Hear from our graduates

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Chiamaka

I am grateful for this opportunity to progress with sound knowledge and skills to be competent in the clinical research field. As an aspiring clinical research professional, this talent program is a step forward to gaining professionalism in clinical

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research alongside my experience on the job. I will ensure others can benefit as I did from VIARES.

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Khilna

The VIARES CRA Academy has been exceptional, and I give a great deal of credit to the VIARES team for creating a superior program and being well-organized, responsive, and helpful. The trainers were always available to guide us accordingly

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and provide real-life insights. VIARES’s investment in their students goes above and beyond.

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Customer Reviews

Based on 11 reviews
91%
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9%
(1)
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R
Rhy P

Clinical Study Coordinator Academy

L
Liudmyla Sysa

Clinical Study Coordinator Academy

P
Petya Georgieva
I wholeheartedly recommend the course

Thank you for the comprehensive presentations and shared experience. This course lays a solid foundation of knowledge about the different roles in the clinical research field.

D
Dr Joseph Alpha Kallon
Theory meets Practicals

The Clinical Study Coordinator 1 course provided some refresher training for me and new ways of understanding activities done in the past. I really enjoyed the course as it mirrors my everyday work as a deputy study coordinator.

M
Molly Nye

Clinical Study Coordinator II

reviews curated by judge.me

-50%

BESTSELLER

Clinical Study Coordinator Academy
Typical annual market salary:
$32,000 to $83,000+

Original price was: € 199,90.Current price is: € 99,90.

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PATRICIA HOLLIS

in the industry for 21 years

Patricia has been in the clinical research industry for over 20 years. She began her career as a clinical research coordinator at the Medical College of Virginia where she coordinated pharmaceutical and PI initiated trials. She has been a Clinical Research Associate for 16 years and has had the opportunity to serve as a Lead CRA, Clinical Trial Manager, Auditor, Mentor, and Clinical Research Instructor. She has worked in all phases of research and is experienced in numerous therapeutic areas, including Oncology, Endocrinology, CNS, Immunology, Cardiology, Nephrology and Device. Currently, she is a contract CRA through her company, The Hollis Group, LLC, which she owns with her husband and serves as a consultant at local research sites. Patricia completed a Bachelor of Science degree at Virginia Commonwealth University, MBA at Texas Woman’s University and has had specialized oncology training from the Oncology of Nursing Society.

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  • Personalized certificate upon completion
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  • Online access to our learning management system

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