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Clinical Trials Assistant Academy

Our Clinical Trials Assistant Academy gives you full access to all of our online clinical research courses to start your clinical research career. Get certified and acquired knowledge, skills and competencies to start at an exiting clinical research career as Clinical Trials Assistant and other roles.

Courses included: Clinical Trials Assistant – Study Start Up Specialist – Clinical Trial Master File Specialist – Clinical Research Data Manager

THE CTA ACADEMY PROVIDES YOU WITH

Industry required competencies for many starting roles including


    • introduction to clinical research
    • understanding GCP and general regulatory requirements
    • trial monitoring support and administration
    • setup, maintenance and archiving of a trial master file
    • including investigator site file and pharmacy site file
    • Start Up and core submission documents
    • ICFs / Assents requirements, adaptation and GDPR
    • EudraCT and upcoming EU regulations
    • IP release document requirements
    • 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 Trials Assistant

  • What is clinical research
  • How are clinical trials managed
  • Who can participate in clinical trials
  • What are the key phases and roles in clinical trials
  • Background of medicines development
  • Research and discovery stage & product development
  • Clinical development
  • Regulatory submission, Health Technology Assessment, lifecycle management
  • ICH GCP and other applicable regulations
  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections
  • The Study Protocol
    • Elements of a Study Protocol according to ICH GCP
    • Trial Design
    • Methodologies
  • Roles and Responsibilities
    • Ethics Committees
    • Sponsor / Monitor
    • Investigator
    • Competent Authority
  • The CTA as member of the clinical study team
  • Typical activities of the CTA related to:
    • Managing Essential Documents
    • Handling Investigational Medicinal Product
    • Supporting Data Management
    • Interaction with Ethics Committees and Regulatory Bodies

Trial Master File specialist

  • Background of TMF management
  • The importance of documentation within a clinical trial
  • Basic insights into the TMF structure and its content 
  • Main tasks and responsibilities of a TMF Specialist
  • Detailed insights into the TMF structure and its content
  • Essential documents 
  • Detailed insights into the TMF set up and its index
  • Document Management Plan
  • TMF Archiving
  • The importance of documentation within a clinical trial
  • Basic insights into the ISF structure and its content
  • Basic insights into the PSF structure and its content 

Study Start Up specialist

  • SSU structure, responsibilities and involvement in project life-cycle
  • Main groups of core study submission documents
  • Core documents required for submissions
  • Documents development responsibilities
  • Core submission package
  • Critical path for efficient start up
  • Country level documents for submission
  • Country documents development responsibilities
  • Country adaptations
  • ICFs / Assents requirements, adaptation and GDPR
  • Labels
  • Translation requirements
  • Site level documents
  • Country submission packages
  • VHP process and timeliness
  • VHP submission process vs. regular country submission process – differences
  • VHP advantages and disadvantages
  • VHP PLUS
  • Upcoming regulations
  • Protocol Amendments in VHP
  • Main regulatory bodies and their responsibilities
  • Submission strategies and dependencies (main groups on diagrams)
  • Submissions and approval timelines
  • Comments, conditional approvals, rejections
  • EudraCT study registry
  • EudraCT GMP database
  • EudraCT Annex 1
  • EudraCT Annex 2
  • EoT notification form
  • Upcoming EU regulation
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing

Clinical Data Management

  • Identify concepts in ethical reasoning which may influence our analysis & results from data.
  • Understand the process of data curation, & the custodial duty of data science. Learn some essential tools used by data scientists.
  • Investigate & manipulate data to learn its metadata, shape & robustness.
  • Identify an appropriate chart & present data to illustrate its core characteristics.
  • Recognise the importance & process for applying concepts of privacy & anonymity.
  • Integrate methods for metadata & archival into data management.
  • Investigate data distribution & confidence, & reshape using Pandas.
  • Illustrate core analysis with histograms & box plots.
  • Determine implications in collection, mining & recombination of open- & digital data.
  • Employ methods for presenting data for synthesis & usage, & employing methods for data maintenance.
  • Perform techniques in randomness & probability to understand distribution & likelihood.
  • Apply histograms, line charts & scatter plots to illustrate probability.
  • Acknowledge the privacy & confidentiality issues in data storage & security of personal data.
  • Recognise responsibilities & mechanisms for securing data-at-rest & data-in-motion.
  • Apply linear & continuous sampling methods to assess normal distributions.
  • Plot distributions as normal histograms & continuous curves.

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.

4 VIARES CERTIFICATES

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the program and your exams, you get 4 (Clinical Trials Assistant, Trial Masterfile Specialist, Study Start Up Specialist, Clinical Data Management) 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.

Obtaining your certificates can provide several potential benefits, including:

  • Professional recognition: A Clinical Research certification demonstrates to employers and colleagues that you have the knowledge and skills necessary to excel in your role as a clinical research professional.
  • Competitive edge: In a competitive job market, having a Clinical Research certification can set you apart from other candidates and increase your chances of being hired or promoted.
  • Career advancement: With a Clinical Research certification, you may be eligible for higher-paying and more advanced roles in the field.
  • Increased knowledge and skills: Pursuing a Clinical Research certification can help you gain a deeper understanding of clinical research methods, regulations, and ethical considerations, which can help you perform your job more effectively.
 

Overall, obtaining a Clinical Research certification can be a worthwhile investment for those who are committed to their career in clinical research and interested in advancing their knowledge and skills.

Your expert instructors

Alvi
Vincent

Katharina
Zacher-Aued

Hear from our graduates

Alimamy

VIARES Clinical Research Talent Program is an excellent and timely opportunity in the era of new drugs and vaccines development. It is best fitted to equip those with interests in clinical research with the knowledge and skills to deliver well

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in these industries. The holistic nature of the program consolidates and complements my practical understanding of vaccines and drugs development clinical trials and pharmacovigilance. I undoubtedly recommend it to people with career aspirations in clinical research.”

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Francis

VIARES provided me with the formal training and skills that would allow me to achieve my career and personal goals. A chance to complete this course afforded me the opportunity to experience the clinical trial training from different experienced

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professionals, whilst providing me with exposure to the international arena of clinical research management and the global concerns while interacting with the multi-national specialists and students. I developed skills in report writing, clinical trial design, and data management among others. I would recommend the VIARES ACADEMY for anyone eager to set strong foundations in clinical research whilst remaining all rounded.

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Customer Reviews

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Nhlamulo Wendy Baloyi

Clinical Trials Assistant Academy

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Ereme Olajumoke
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.

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ANCA CRISTINA Pop

Clinical Trials Assistant Academy

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Ioan Alexandra

Excellent

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Clinical Trials Assistant Academy

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BESTSELLER

Clinical Trials Assistant Academy
Typical annual market salary:
$38,000 to $140,00+
This Course includes

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 99,90

 9,90 / month for 12 monthsPay monthly

BARTEK JAROSZ

18 Years experience

Bartek has 18 years experience in clinical research business, mostly spent at largest global Contract Research Organizations. At Quintiles he was responsible for pioneer development of clinical start-up and regional contract departments. He served as executive member of clinical start-up leadership team at INC Research, acting as global head of site contract division. His most recent experience includes support for pharmaceutical organizations in various project specific roles. Bartek enables biopharma to get their sites up and running faster. He is author of several training programs about site contract related matters and successfully delivered to hundreds of individuals worldwide.

GABRIELE DISSELHOFF

38 years in pharmaceutical development

Gabriele is currently the Managing Director of CRQS (Creative Regulatory & Quality Solutions), specializing in Strategic Regulatory Affairs, Quality Management, Organizational Development and Change Management. She has 38 years of experience under her belt in pharmaceutical development, with 29 years in pharmaceutical industry (Merck KGaA, Abbott) and 9 years consulting. She has extensive industry experience in regulatory affairs, clinical research and clinical quality assurance, and a thorough knowledge of document management and electronic submissions.

GAVIN CHAIT

Data Scientist at Whythawk

Gavin Chait is a Data Scientist at Whythawk, which specializes in integrated open data consulting, and training for open knowledge, freedom of information, and economic development projects. He spent more than a decade in economic and development initiatives in South Africa. He was a commercial director at the Open Knowledge Foundation, and led the implementation of numerous open data projects around the world. Gavin has twenty years of experience in teaching at all academic levels, and is a passionate advocate for knowledge development through open access to data and freedom of information.

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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