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

COURSE Content

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

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

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.

There are several reasons why you might consider getting a CRA certification:

Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.

Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.

Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.

Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.

Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.

Hear from our graduates

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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Matthew

As someone who has no monitoring experience, the CRA Academy made it easy for me to understand how the Clinical Research field works. The instructors are easy to understand and they accommodate all queries that we have.

reviews curated by judge.me

Why become a CRA?

There are several reasons why you might consider becoming a Clinical Research Associate (CRA):

Opportunity to contribute to developing new drugs and medical devices: As a CRA, you will be involved in clinical trials that test the safety and effectiveness of new drugs and medical devices. This is an opportunity to contribute to the development of new treatments that can improve the lives of patients.

Career growth potential: Clinical research is a growing field, and there is a high demand for experienced CRAs. With experience, you can advance to positions with greater responsibility and higher pay.

The salary of a CRA can vary depending on several factors, including the location, type of employer, level of experience, and educational background.

According to the data from the U.S. Bureau of Labor Statistics, the median annual salary for clinical research associates was $70,720 as of May 2020. However, salaries can range from around $47,000 to over $125,000 per year.

Overall, a career as a CRA can be financially rewarding, with opportunities for career advancement and increased earning potential over time.

Flexibility: CRAs can work for pharmaceutical companies, contract research organizations, academic institutions, or government agencies. There are also opportunities to work remotely or travel to different clinical trial sites.

Personal fulfillment: As a CRA, you will be part of a team that is working to improve patient outcomes. This can be personally fulfilling and rewarding work.

Ultimately, whether or not you should become a CRA depends on your interests, skills, and career goals. If you are passionate about medical research, enjoy working in a team environment, and have strong attention to detail, a career as a CRA may be a good fit for you.

WHAT ARE TYPICAL RESPONSIBILITIES OF A CRA?

The typical responsibilities of a CRA can vary depending on the employer, the stage of the clinical trial, and the size of the study team. However, some common responsibilities of a CRA may include:

Study site management: CRAs are often responsible for managing the study sites participating in a clinical trial. This may involve conducting site feasibility assessments, training site staff on study protocols and procedures, and monitoring site performance.
Data collection and review: CRAs may collect and review study data to ensure that it is accurate and complete. This may involve reviewing medical records, lab reports, and other documentation.
Adverse event monitoring: CRAs are responsible for monitoring adverse events reported by study participants and ensuring that they are reported and managed appropriately.
Regulatory compliance: CRAs must ensure that the study is conducted in accordance with relevant regulations and guidelines, such as good clinical practice (GCP) and the International Conference on Harmonisation (ICH) guidelines.
Documentation: CRAs must maintain accurate and complete study documentation, including case report forms (CRFs), study logs, and other study-related documents.
Communication: CRAs must communicate effectively with study team members, site staff, and study participants to ensure that the study is conducted smoothly and that any issues are addressed in a timely manner.
Subject recruitment: CRAs may be involved in supporting recruitment of eligible study participants.

Overall, the role of a CRA is multifaceted and requires a high level of attention to detail, organization, and communication skills.

Is this the best option for me?

To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.

In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.

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 - CRA clinical research associate

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Clinical Research Associate – Enterprise

€ 239,90

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€ 239,90

Clinical Research Associate – Enterprise

COURSE Content

VIARES CERTIFICATE

Hear from our graduates

Magda

Matthew

Why become a CRA?

WHAT ARE TYPICAL RESPONSIBILITIES OF A CRA?

Is this the best option for me?

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