Cross Over Program
Clinical Research Associate

The Cross Over Program Clinical Research Associate (xCRA) is specifically designed for anyone with a life-science education and work experience not yet working in clinical research. This Cross Over Program will help you to cross the path from your current job into the clinical research industry.

THE xCRA WILL PROVIDE 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

4 personal coaching sessions with our talent specialist

find the right job for you
define your application strategy and actions
optimize your communication and information
prepare for your interview

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.

Program Competencies

Introduction to Clinical Research

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

GCP Certification

ICH GCP E6(R2) Certificate
Investigator Oversight

Medicines Development Process, Good Clinical Practice

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

Regulatory Environment in the EU and USA

Applicable international and national regulations
ICH GCP E6 (R2)
FDA Regulation
Quality Assurance: Audits and Inspections

Clinical Trial Design & Clinical Research Roles and Responsibilities

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 and Initiating Clinical Trial Sites

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

Monitoring and Closing Clinical Trial Sites

Effective Monitoring
- Planning, Conducting, Documenting, and Reporting Monitoring Visits
- Managing Issues
Closing Investigational Sites
- Organizing the Close-Out Visit
- Documentation
- Reporting

Patient Protection & Adverse Events

Patient Protection
- Patient Information
- Collecting Patient Consent
- Special Patient Populations
Adverse Event Reporting
- Types of Adverse Events
- Identifying and Reporting Serious Adverse Events

Investigational Medicinal Product Management

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 Management for Clinical Research Associates

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 Concepts and Regulatory Guidelines

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

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

Cancer and Treatment Goals

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

Cancer Treatments

Examine various cancer treatments and their adverse reactions
Explore alternative treatment options

Chemotherapy and Radiation

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

Tumor Staging and Tumor Grading

Differentiate between cancer and uncontrolled tumor growths
Recognize the six major categories of cancer classifications
Understand components of medical terminology related to cancer

Oncology Study Design

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

Clinical Assessments

Recognize common clinical assessments related to oncology trials
Gain proficiency in reviewing clinical reports
Identify disease history and common Inclusion/Exclusion criterion

Lines of Therapies

Define each line of therapy and understand the timing of each line
Understand dosing design in oncology studies

Adverse Events, DLTs and Dose Modifications

Recognize most common Adverse Events and be able to discuss clinical events related to oncology studies
Recognize common toxicities and understand the DLT process

Identifying Oncology Subjects and Enrollment 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

Source Documents and Clinical Reports

Pathology
Radiology
Clinical Reports and Source
Medical
Surgical

RECIST 1.0, RECIST 1.1

Distinguish between RECIST 1.0 and RECIST 1.1
Utilize appropriate oncology disease progression algorithms
Understand disease progression

Oncology Site and Delegation Log

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

The Oncology Monitor

Learn Sponsor/CRO expectations of Oncology Monitors
Understand the stress and pressures of monitoring oncology studies
Learn time saving techniques while monitoring

Application process

Set Clear Goals

Setting clear goals and expectations is the crucial first step when it comes to your job search.

Get Trained & Certified on the Skills needed

Understand WHAT are the required skills of your dream job and how to acquire them

CV, CV, CV!

you will address THE most important piece to get your dream job

Ace Your Interview

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

Negotiate and Get What You Truly Deserve.

Personal coaching

find the right job

set a realistic job goal
match your goal with your skills and competencies
be clear about your strength and weaknesses

define your application strategy and actions

select the target jobs to apply for
define what you need to do to be successful in your application

optimize your communication and information

align your information and your documents to match the requirements of the selected target jobs
ensure your skills and competencies are clearly understandable and meet your real situation
send your application to the right recipient via the right media

prepare for your interview

once you are invited to an interview, we will do a preparation interview with you
simulate the situation and understand what could come to you

VIARES CERTIFICATE

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the program and your exam, you get your personal “xCRA 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.

Obtaining your xCRA certification 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

Hear from our graduates

Sundass

Being a Certified Clinical Research Coordinator myself, I can tell this with confidence that VIARES Clinical Research Academy program is a top-notch course for clinical research industry practitioners and professionals. It covers all aspects of Clinical

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research and trials process. The modular approach, combined with assignments and quizzes at end of each module keeps the students engaged as the program progresses. I would recommend this course not only to prospective Clinical Research professionals but also to those who are already working in the clinical research industry.

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Sarah

VIARES has unique trainings for Clinical Research Associates. The training is well structured and detailed including examples and content presented by industry experts . The excellent training received at the Academy provides strong support and

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is therefore a great stepping stone to working in operations in the Pharma industry as well as CROs worldwide. Thanks VIARES for the opportunity to enhance and develop my skill set!

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reviews curated by judge.me

why should I become a clinical research professional?

There are several potential reasons why you might consider becoming a clinical research professional, including:
Contributing to medical advances: By working in clinical research, you have the opportunity to contribute to the development of new treatments and therapies that can improve people’s lives.
Job growth and stability: Clinical research is a growing field with many job opportunities, and the demand for skilled professionals is likely to continue to increase in the future.
Competitive salaries: Many jobs in clinical research offer competitive salaries, and with experience and advanced education or certifications, you may be able to earn even more.
Career variety: Clinical research involves many different types of roles and responsibilities, which can provide you with the opportunity to explore different areas of interest and develop a diverse set of skills.
Intellectual challenge: Clinical research involves a significant amount of critical thinking, problem solving, and attention to detail, which can be intellectually stimulating and rewarding.

Overall, becoming a clinical research professional can be a fulfilling and rewarding career path for those who are interested in contributing to medical research and improving patient outcomes.

what are the typical responsibilities of an entry level clinical research role?

The specific job responsibilities of an entry level clinical research role can vary depending on the position and the employer. However, here are some common job responsibilities that you might expect to encounter in an entry level clinical research position:

Assisting with protocol development: Entry level clinical research professionals may be responsible for helping to develop study protocols, which describe the goals, methods, and procedures for a clinical trial or research project.
Preparing study documents: This may include preparing informed consent forms, case report forms, and other study documents necessary for the conduct of a clinical trial.
Coordinating study visits: Entry level clinical research professionals may help coordinate patient visits and assist with data collection during these visits.
Managing study data: This can include entering data into electronic databases, performing quality checks on the data, and generating reports as needed.
Assisting with study recruitment: Entry level clinical research professionals may help with recruiting and screening study participants.
Managing study supplies: This can include ordering and organizing study supplies, such as medications or lab kits.
Assisting with regulatory compliance: Entry level clinical research professionals may assist with ensuring that the study is conducted in compliance with applicable regulations and guidelines.

Overall, entry level clinical research roles often involve a mix of administrative and clinical tasks, and may require working collaboratively with a variety of team members to ensure that the study is conducted effectively and efficiently.

IS THIS THE BEST OPTION FOR ME?

To become a clinical research professional, there are several educational and experiential backgrounds that can be helpful, including:

Education: A bachelor’s or master’s degree in a relevant field such as life sciences, nursing, or medicine can be helpful. Some employers may also prefer candidates with a degree in a related field, such as statistics or public health.
Clinical experience: Many clinical research positions require prior clinical experience, such as working as a nurse, medical assistant, or physician. This experience can provide valuable insight into the patient experience and medical care delivery.
Research experience: Experience working on research projects, such as in a lab or academic setting, can be helpful in demonstrating an understanding of the research process.
Regulatory experience: Experience working with regulatory bodies such as the FDA can be valuable for clinical research professionals working in areas such as clinical trial management or regulatory affairs.
Computer skills: Clinical research professionals should be comfortable using computers and various software programs, including electronic data capture (EDC) systems and statistical analysis software.

Overall, a combination of education and experience can be helpful for those seeking a career in clinical research. It’s important to stay up-to-date with the latest industry trends and regulations, and to continually seek out opportunities to develop your knowledge and skills in this rapidly-evolving field.

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.

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BESTSELLER

Cross Over Program
Clinical Research Associate

Typical annual market salary:
$47,000 to $125,000+

€ 39,90 / month for 12 months

€ 249,90Life-Time

This Course includes

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€ 249,90

€ 39,90 / month for 12 monthsPay monthly

Cross Over Program
Clinical Research Associate

THE xCRA WILL PROVIDE YOU WITH

Program Competencies

Application process

Personal coaching

VIARES CERTIFICATE

Your expert instructors

BARTEK JAROSZ

Gabi Disselhoff

GAVIN CHAIT

Joanna Wilinska Mackowiak

Andreas
Beust

PATRICIA
HOLLIS

Hear from our graduates

Sundass

Sarah

why should I become a clinical research professional?

what are the typical responsibilities of an entry level clinical research role?

IS THIS THE BEST OPTION FOR ME?

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Monthly

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Cross Over Program Clinical Research Associate

THE xCRA WILL PROVIDE YOU WITH

Program Competencies

Application process

Personal coaching

VIARES CERTIFICATE

Your expert instructors

BARTEK JAROSZ

Gabi Disselhoff

GAVIN CHAIT

Joanna Wilinska Mackowiak

AndreasBeust

PATRICIAHOLLIS

Hear from our graduates

Sundass

Sarah

why should I become a clinical research professional?

what are the typical responsibilities of an entry level clinical research role?

IS THIS THE BEST OPTION FOR ME?

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