The VIARES Clinical Research Associate (CRA) course is a self-paced, online clinical research associate training program for people preparing to monitor clinical trials. You work through eight core modules, from Good Clinical Practice to site monitoring and close-out, then pass a final exam to earn a VIARES certificate that anyone can verify.
Last updated October 12, 2026.
This course is an entry-level pathway into clinical trial monitoring for aspiring clinical research associates. It gives you the knowledge a CRA uses every day: GCP, regulations, protocols, site visits, safety reporting, investigational product handling and clinical trial data. It does not replace hands-on experience, and most research sponsors and CROs still expect some clinical research work history before they hire a field CRA. The course fits best if you belong to one of these groups.
A degree in biology, biochemistry or pharmacology, or lab work as a research assistant.
You know patients and medication; the course adds the sponsor and monitoring side.
Coordinators, CTAs, study nurses and in-house CRAs preparing for a monitoring role.
A health or science background, but outside the clinical research field today.
Life-science graduates and scientists. You hold a degree in biology, biochemistry, pharmacology or a related field, or you work in a lab as a research assistant, and you want to move into clinical trials. The course shows how research becomes a regulated trial and what a monitor checks at a site.
Nurses, pharmacists and physician assistants. You already know patients, medication and clinical documentation. The course adds the sponsor and monitoring side: informed consent verification, adverse event reporting, drug accountability and the regulatory framework in the EU and the United States.
Site and sponsor staff aiming for monitoring. You work as a clinical research coordinator, clinical trial assistant, study nurse or in-house CRA and want a structured preparation for a monitoring role, including written practice tasks on site selection, monitoring reports and close-out.
Career changers from healthcare and pharma. You have a health or science background but work outside the clinical research field today. The course gives you a complete picture of the CRA role before you apply for an entry-level role such as clinical trial assistant or coordinator.
If you do not have a science or health degree yet, a site or sponsor support role is usually the faster way in. The Clinical Trials Assistant course and the Clinical Study Coordinator course prepare you for those roles. What you need for the CRA course: good English reading skills, a computer with internet access, and the ability to upload your assignments as PDF files. You do not need a degree in clinical research to enroll.
Each of the eight training modules follows the same three steps: watch the microcourses, complete a written assignment that applies the content to a realistic case, and pass a 30-minute knowledge check (70% pass mark, unlimited attempts). Assignments are practice for you and are not graded.
Right after you enroll, you download a Confirmation of Enrollment. You can add it to your LinkedIn profile or job applications to show that you are in training.
Printable handouts of the microcourses are available as a separate order if you like a printed study guide. You do not need them to finish the course; all material required for the exam is on the learning platform.
Before Module 1 you complete two free introductions used across the industry: the ICH Good Clinical Practice course from The Global Health Network (free GCP training of about 45 to 60 minutes, with its own GCP certificate) and TransCelerate’s program on investigator oversight. You also review the quality guidelines of the International Council for Harmonisation (ICH) and the EU rules governing medicinal products.
You will be able to describe how a new medicine moves from target selection through clinical development to regulatory submission, health technology assessment and lifecycle management, and explain how GCP protects patient safety and data integrity.
You will cover:
✓ The background and stages of medicines development
✓ Research and discovery, product development and clinical development
✓ Regulatory submission, health technology assessment and lifecycle management
✓ ICH GCP and other applicable regulations
You will understand how the US and EU regulatory systems work, what happens before, during and after audits and inspections, and what a monitor does when misconduct or fraud is suspected. Instructor: Gabi Disselhoff.
You will cover:
✓ National and international requirements, including ICH GCP
✓ The sponsor’s quality assurance system and standard operating procedures
✓ Audits and inspections, and the monitor’s role in them
✓ Recognizing and handling misconduct and suspected fraud
You will be able to read a study protocol with the elements ICH GCP requires, explain common study design choices, and describe what ethics committees, sponsors, monitors, investigators and competent authorities are each responsible for.
You will cover:
✓ Elements of a study protocol according to ICH GCP
✓ Trial design and methodology
✓ Why protocol compliance protects patients and data
✓ Roles and responsibilities of each party in a trial
You will be able to judge whether an investigator site is suitable, plan and document a site initiation visit, train site staff, and support ethical patient recruitment.
You will cover:
✓ Qualities of a good investigator site and how to assess them
✓ Strategies to upgrade a site through training, staffing or equipment
✓ Planning, running and documenting site initiation visits
✓ Follow-up and escalation of open issues
You will be able to prepare and conduct monitoring visits, assess site performance, escalate problems, and run a close-out visit.
You will cover:
✓ The purpose of monitoring and how to raise site performance
✓ Planning and conducting routine monitoring visits
✓ Planning and conducting close-out visits
✓ Documenting monitoring and close-out visits
You will be able to verify that informed consent was obtained and documented correctly, spot risks to patient safety and data integrity, classify adverse events according to ICH guidelines, and follow the reporting requirements.
You will cover:
✓ Patient information and the informed consent process
✓ Protocol deviations and pharmacovigilance issues at the site
✓ Types of adverse events and the reporting processes, formats and follow-up
✓ Ethical patient recruitment
You will understand how investigational products, comparators and placebo are managed, how randomization and blinding are documented, and how to monitor drug accountability through to final reconciliation.
You will cover:
✓ Accountability, expiry dates, re-supply, storage, security and destruction
✓ Dispensing according to protocol and checking compliance
✓ Randomization, blinding and unblinding procedures
✓ Common findings published by the US Food and Drug Administration (FDA) from its inspections
You will understand how the case report form follows from the protocol, how data collection and validation work, how queries are raised and resolved, and which essential documents must be archived. Instructor: Gavin Chait.
You will cover:
✓ Purpose and structure of paper and electronic case report forms
✓ Monitoring and data validation plans
✓ Raising and resolving data queries
✓ Essential documents, site file and trial master file, and archiving rules
The final exam covers all eight modules. You need 80% of all points to pass and have two attempts; the higher score counts. Plan two uninterrupted hours, because the timer keeps running once you start.
After passing, you download your VIARES certificate as a PDF. A short video in the course shows how to add it to your LinkedIn profile.
Want the full syllabus as a PDF? Download it and get reminders about the course:
You earn the VIARES certificate by passing the final exam at the end of the course. There are no exam dates and no separate exam registration; you take it online when you are ready. Obtaining a CRA certification from VIARES takes three steps: finish the eight modules, pass the exam, download your certificate.
Start anytime: 100% online and self-paced.
8 core modules with case assignments and knowledge checks.
100 questions, 90 minutes, 80% to pass, 2 attempts.
PDF with a personal code employers can check online.
After you pass, you download the certificate as a PDF from the learning platform. It is signed by Dietmar Eglhofer, CEO of VIARES GmbH, and carries a personal verification code. Employers can check that code on the VIARES certificate verification page.
About VIARES: IAOCR 5-star accredited training provider (2018), founded in 2018, with over 53,000 certificates issued (verifiable online) and 12,000+ learners from 120+ countries.
What the certificate shows: you completed a structured clinical research associate training program and passed a timed exam on it. It is a training certificate, not a professional certification. The section on ACRP and SOCRA below explains the difference.
VIARES instructors with hands-on industry experience teach the eight core modules of the CRA course. Further VIARES faculty teach the specialist courses that CRA graduates often take next.
Regulatory environment in the EU and USA
Managing Director of CRQS; 38 years in pharmaceutical development, including Merck KGaA and Abbott.
Managing Director of CRQS with 38 years in pharmaceutical development: 29 years in industry, at Merck KGaA and Abbott, and 9 years in consulting. Her fields are regulatory affairs, clinical research, clinical quality assurance and document management.
Data management for CRAs
Data scientist at Whythawk. He teaches how trial data are captured, validated and kept traceable.
Specialist faculty: oncology monitoring and study coordinator courses
Patricia Hollis brings 21 years of industry experience and teaches the VIARES oncology monitoring and clinical study coordinator courses.
Specialist faculty: Trial Master File Specialist course
Team Lead Clinical Document Management at GCP-Service; former CRA and TMF manager.
Team Lead Clinical Document Management at GCP-Service. A biologist who started in polar research, she moved into clinical research as a CRA and TMF manager and now focuses on risk-based document management.
Specialist faculty: Trial Master File Specialist course
Head of the TMF department at GCP-Service, with two master’s degrees, in applied microbiology and in biomedical immunology.
Does this course make me a certified clinical research associate? No course does that on its own. The best-known CRA credentials, the Certified Clinical Research Associate (CCRA) from ACRP and the Certified Clinical Research Professional (CCRP) from SOCRA, are experience-based: you can sit their exams only after documented work in clinical research. The VIARES course is training plus a certificate of completion. It prepares you for the knowledge those exams test and for the entry roles that build the required hours.
At a glance: who issues each credential and what you need before you can sit the exam. Swipe sideways to see all columns.
| VIARES CRA certificate | ACRP CCRA | SOCRA CCRP | |
|---|---|---|---|
| Issued by | VIARES GmbH, Vienna | Association of Clinical Research Professionals | Society of Clinical Research Associates |
| What you need to sit the exam | Complete the VIARES CRA course | 3,000 hours of verifiable work experience; ACRP may grant one 1,500-hour waiver, for example to graduates of an education program that meets ACRP’s criteria | Two years of full-time work as a clinical research professional (or 3,500 part-time hours) within the last five years; shorter routes exist with a clinical research degree or certificate plus one year |
| Exam | 100 questions, 90 minutes, 80% to pass | 125 multiple-choice questions in 180 minutes | See SOCRA’s candidate information |
| What it shows | You completed CRA training and passed an exam on it | Professional certification for practicing CRAs | Professional certification for clinical research professionals |
| Cost | see the current price on this page for the complete course including the exam and the certificate, paid once in your currency | Exam fee only: US$435–460 for ACRP members and US$485–600 for non-members (membership US$160 per year); training is not included | Exam fee only: US$510–625 depending on membership and region; retest US$390; training is not included |
| Renewal | No renewal fee; the certificate stays verifiable online | Recertify every 2 years through continuing education | Recertify every 3 years: 45 hours of continuing education plus a US$350 fee |
A realistic sequence looks like this: complete a structured course, start in a role that counts as clinical research experience (clinical trial assistant, coordinator, in-house CRA or study start-up), then apply for ACRP certification (CCRA) or the SOCRA CCRP once you have the hours. If an employer asks for an industry-recognized certification for practicing CRAs, this is what they usually mean. Whether a training program counts toward an experience waiver is decided by ACRP or SOCRA on application, so check their current rules before you rely on it.
Requirements and fees as published by ACRP and SOCRA (recertification), checked October 12, 2026.
Free courses are a good starting point; VIARES itself asks you to complete one in the clinical research basics section. The differences lie in CRA-specific depth, written practice and a timed final exam.
At a glance: cost, format, practice tasks and final exam side by side. Swipe sideways to see all columns.
| VIARES CRA course | Free resources (NIH IPPCR, TGHN ICH GCP) | CCRPS CRA certification | |
|---|---|---|---|
| Cost | see the current price on this page, paid once in your currency | Free | $495 standard tier; $1,500 mentor and job-support tier |
| Format | Self-paced online, 80–100 hours | Self-paced online; the TGHN GCP course takes about 45 to 60 minutes | Self-paced online |
| Focus | The CRA job: sites, monitoring, close-out, safety, investigational product, data | General clinical research principles (IPPCR) or GCP only (TGHN) | The CRA job |
| Practice tasks | 8 written case assignments, e.g. a monitoring report and an investigational product flowchart | Quizzes | See ccrps.org |
| Final exam | 100 questions, 90 minutes, 80% to pass, 2 attempts | Course-specific quiz or exam | 50 questions, 70% to pass, 2 attempts |
| Certificate | PDF with public verification code | Certificate of completion (varies by course) | Certificate of completion |
| Is it ACRP CCRA or SOCRA CCRP? | No | No | No |
Choose free resources to test your interest in clinical research. Choose a paid CRA course if you want a full monitoring syllabus, case practice and an exam result you can show. CCRPS details from app.ccrps.org and the CCRPS FAQ, checked October 10, 2026; providers change prices and formats, so check their sites. Free course details: NIH IPPCR and TGHN ICH GCP.
A clinical research associate, often called a clinical monitor, is one of the study monitors a sponsor or contract research organization (CRO) assigns to a trial, usually within its clinical operations team. The core of the role of a clinical research associate is protocol adherence and data quality: the CRA makes sure each investigator site runs the trial according to the protocol, ICH GCP and the applicable regulations, and that the clinical data reported to the sponsor match the source records. Research sponsors own protocol development and study design; the CRA checks that the research sites follow the final protocol.
The main responsibilities of a CRA, each covered in a module of this course:
Many sponsors now combine on-site visits with remote monitoring: the CRA reviews clinical trial data, data collection and open queries from the office between visits. VIARES teaches this in a separate Remote & Centralized Monitoring course (40 hours).
A CRA also works with many stakeholders: investigators, study coordinators and research administrators at the site; the sponsor’s clinical trial management team and project manager; data management, safety and ethics committees (institutional review boards, or IRBs, in the United States). Clear communication, organization and written reporting matter as much as GCP knowledge.
Most CRAs do not start as CRAs, and a career in clinical research rarely begins with a field monitoring job. A common career as a clinical research associate looks like this:
Proper training shortens the first step. Interviewers for clinical research associate roles expect you to know GCP, the regulations and the monitoring routine before you get hired, and CRA positions usually list trial experience as a requirement. Job opportunities exist across the clinical research industry, at sponsors, CROs and sites, and the research industry also needs clinical researchers in data management, safety and regulatory roles.
Read our article on whether the CRA role is an entry-level job for graduates, browse graduate stories, and look at current openings on the VIARES job board. If you plan the CTA or coordinator route first, the Clinical Trials Assistant and Clinical Study Coordinator courses cover those roles.
Clinical Research Associate
Verified ownerI am very satisfied with the course.Best money investment, especially for the beginners as me.
Verified ownerEducative indeed
Verified ownerVery informative but the payment automatically came off my account before I could apply my discount code so that was a little disappointing. Once I finish I can say more
Verified ownerClinical Research Associate
Verified ownerCliniical Research associate Tutorials were very clear and tutors very friendly. Queries were responded to very promptly.
Verified ownerClinical Research Associate
Verified ownerCRA the modules are very informative
Verified ownerExcellent...Game-changer!!! The Viares CRA course has been an incredible boost to my career in Clinical Research. The practical knowledge, expert guidance, and real-world insights have truly set me up for success in this field. I highly recommend this course to anyone looking to grow in Clinical Research!"
Verified ownerOverall, I found the CRA course to be informative and well-organized. The course covered important topics such as GCP guidelines, clinical trial processes, data management, and regulatory requirements. The content was detailed, organized, and suited for an online learning environment. I appreciated the use of real-world examples to illustrate complex topics.
Most people take four steps. First, earn a bachelor’s degree in a life science, nursing, pharmacy or another health field. Second, get proper training in GCP and clinical trial monitoring, for example with a CRA course. Third, gain experience in an entry role such as clinical trial assistant, clinical research coordinator or in-house CRA. Fourth, apply for CRA positions once you have that experience. Later, the ACRP CCRA or SOCRA CCRP credential can document your experience.
It depends on where you start. If you have a science or health degree but no trial experience, a structured CRA course gives you the vocabulary, regulations and monitoring routines that interviews for CTA, coordinator and in-house CRA roles test. It does not guarantee a job. If you already monitor trials, the ACRP CCRA or SOCRA CCRP credential will add more to your profile than another training certificate.
The CCRA is worth considering once you work as a CRA. It is a professional certification from ACRP that documents your experience and a passed exam. It is not an option at the start of your career: you need 3,000 hours of verifiable work experience before you can sit the exam, and ACRP may grant a 1,500-hour waiver. Whether it pays off depends on your employer and market, so check what CRA job postings in your region ask for.
It depends on which kind you mean. You get a training certificate, such as the VIARES CRA certificate, by completing a course and passing its exam: enroll, finish the eight modules, pass the final exam with 80%, and download your certificate. A professional certification, such as the ACRP CCRA, requires documented work experience first, then an application and exam registration with ACRP. You do not need a certification by law to work as a CRA; employers set their own requirements.
Rarely directly. Most sponsors and CROs hire field CRAs who already have clinical research experience, often as a clinical trial assistant, coordinator or in-house CRA. Training helps you get into those roles and prepares you for the move into monitoring. Some employers run trainee or associate CRA programs for graduates, but they are competitive and usually ask for a life-science or nursing degree.
Plan 80–100 hours in total. The course is self-paced with no fixed schedule, so the calendar time depends on you: at five hours a week you finish in about four to five months, and with a full-time effort in a few weeks. The final exam itself takes up to 90 minutes.
It is a training certificate issued by VIARES GmbH in Vienna, an IAOCR 5-star accredited training provider (2018). Each certificate carries a personal code that anyone, including an employer, can check on the VIARES verification page, and VIARES has a track record of over 53,000 certificates issued (verifiable online). It is not a professional certification like the ACRP CCRA or SOCRA CCRP. How much weight an employer gives it varies; what it documents is completed CRA training and a passed exam.
A clinical research coordinator (CRC) works at the trial site, for the investigator: screening and scheduling participants, collecting data and keeping site records. A clinical research associate (CRA) works for the sponsor or CRO and monitors several sites, checking that they follow the protocol, GCP and regulations. Many CRAs worked as CRCs first.
Most CRA job postings ask for a bachelor’s degree in a life science, nursing, pharmacy or another health field. You can take the VIARES course without a degree, but if you have none, plan on an entry role such as clinical trial assistant first and build experience from there.
The course fee is shown in your local currency at the top of this page and at checkout, based on your location. Published prices include Austrian VAT; local VAT, where applicable, is shown during checkout. Two exam attempts are included in the fee. Extra exam attempts are sold separately.
Yes. The CRA course comes with a 5-day no-questions-asked money-back guarantee. If the course is not right for you, email academy@viares.com within 5 days of purchase and you get your money back.
You have two attempts included, and the higher score counts toward your certificate. If you do not reach 80% in either attempt, you can order an exam extension with two more attempts. The module knowledge checks have unlimited attempts, so use them to find gaps before the final exam.
The CRA course teaches ICH GCP principles throughout and the regulatory framework in the EU and USA. ICH adopted the revised guideline E6(R3) in January 2025. For a focused update on what changed, VIARES offers a separate course, Navigating ICH GCP E6(R3).
Enroll now, work through the 13 sections at your own pace, and earn a certificate employers can verify. Your enrollment is covered by the 5-day no-questions-asked money-back guarantee. Questions before you start? Email our admissions team at academy@viares.com.
