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Clinical Research Associate Academy Pharma Pro Net

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 Research Associate, In-House Clinical Research Associate or similar.

Courses included: Clinical Research Associate – Remote & Centralized Monitoring – The Oncology Monitor

THE CRA ACADEMY PROVIDES YOU WITH

Industry required competencies for a Clinical Research Associate role including

    • introduction to clinical research
    • understanding GCP and general regulatory requirements
    • on-site trial monitoring
    • remote and centralized monitoring
    • monitoring oncology trials
    • patient protection and informed consent
    • handling of adverse events
    • data management basics for clinical trials

 

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. This is ideal for anyone with a current employment.

ACADEMY CONTENT

Clinical Research Associate

  • 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
  • ICH GCP E6(R2) Certificate
  • Investigator Oversight
  • 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
  • Selecting an Investigational Site
    • Assessing Investigational Sites
    • Training and Upgrading Investigational Sites
  • Initiating Investigational Sites
    • Organizing the Initiation Visit
    • Setting up the required documentation – Essential Documents
  • Effective Monitoring
    • Planning, Conducting, Documenting, and Reporting Monitoring Visits
    • Managing Issues
  • Closing Investigational Sites
    • Organizing the Close-Out Visit
    • Documentation
    • Reporting
  • Patient Protection
    • Patient Information
    • Collecting Patient Consent
    • Special Patient Populations
  • Adverse Event Reporting
    • Types of Adverse Events
    • Identifying and Reporting Serious Adverse Events
  • Managing the Investigational Medicinal Product
    • Definition of investigational medicinal product (IMP) / study drug
    • Provision of the IMP
    • Drug Accountability
    • Randomization, blinding and un-blinding processes
    • Managing Expiry Dates
    • Collecting IMP after Site Close-out
  • Data Collection
    • Clinical Research Form (CRFs)
    • Process of Data Collection
    • Data Collection Systems
  • Data Validation
    • Data validation process
    • Query Process
    • Data Quality Assurance

Remote & Centralized Monitoring

  • Background of monitoring concepts
    • Including on-site, remote, and statistical monitoring
  • Regulatory guidance to remote and statistical monitoring
  • Monitoring concepts in the framework of risk-based monitoring
  • From concept to reality: Remote monitoring and centralized statistical monitoring
  • Daily Life of a Remote Monitor
    • Responsibilities
    • Tools and resources
    • How to handle centralized statistical monitoring
    • Monitoring activity and their focus
    • Documentation and follow-up
    • Team interactions
  • What makes a good Remote Monitor

Monitoring Oncology Trials

  • Understand the characteristics of cell formation, the major causes of cancer and global impact of the disease
  • Examine the impact of Oncology studies and current treatment
  • Be able to discuss available treatments and objectives of treating cancer
  • Examine various cancer treatments and their adverse reactions
  • Explore alternative treatment options
  • Identify common cancer drug and cancer combinations
  • Thoroughly understand the relationship between risk and benefits of tumor therapies
  • Recognize chemotherapy drug types and different principles
  • Differentiate between cancer and uncontrolled tumor growths
  • Recognize the six major categories of cancer classifications
  • Understand components of medical terminology related to cancer
  • Be able to discuss Oncology trial schematics and understand the design features.
  • Be able to describe the four phases of Oncology studies.
  • Understand Endpoint requirements in Oncology
  • Recognize common clinical assessments related to oncology trials
  • Gain proficiency in reviewing clinical reports
  • Identify disease history and common Inclusion/Exclusion criterion
  • Define each line of therapy and understand the timing of each line
  • Understand dosing design in oncology studies
  • Recognize most common Adverse Events and be able to discuss clinical events related to oncology studies
  • Recognize common toxicities and understand the DLT process
  • Be able to discuss recruitment challenges in Oncology studies
  • Describe the screening and enrollment process
  • Understand the role of the medical monitor and various key members during screening process
  • Pathology
  • Radiology
  • Clinical Reports and Source
  • Medical
  • Surgical
  • Distinguish between RECIST 1.0 and RECIST 1.1
  • Utilize appropriate oncology disease progression algorithms
  • Understand disease progression
  • Prepare for challenges with site structure and Delegation of Responsibility at oncology sites 
  • Describe key site staff and associated roles
  • Discuss the key function of site staff
  • Learn Sponsor/CRO expectations of Oncology Monitors
  • Understand the stress and pressures of monitoring oncology studies
  • Learn time saving techniques while monitoring

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 Research Associate, Remote & Centralized Monitoring, Oncology CRA) 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

Joanna Wilinska Mackowiak

Andreas
Beust

Hear from our graduates

Dilay

It was a pleasure to take part in the VIARES Clinical Research Talent Program. I gained so much knowledge and understanding of clinical research. I would recommend it to anyone who is interested in the field of clinical trials.Many thanks to Dietmar

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Eglhofer, the whole team and all amazing tutors for providing this informative and very-well organized program

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Yonca

I am very pleased that got the chance to attend the VIARES Clinical Research Talent program. The online learning platform was very informative, well organized, and very encouraging for the future Clinical Research professionals. I particularly

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enjoyed the online webinars and assignments, which made the content easily understandable by discussing simultaneously with the experts in the field.

I would like to thank everyone in the Viares team who was involved in the preparation and execution of the training. I look forward to attending future training given the opportunity.

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Clinical Research Associate Academy Pharma Pro Net

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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.

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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  • Online access to our learning management system

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