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Clinical Operations Specialist

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 Operations Specialist or similar.

What you will learn

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Understand the full lifecycle of medicines development, including research, discovery, clinical development, and regulatory submission.

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Master Good Clinical Practice (GCP) principles and navigate the regulatory environments in the EU and USA, including compliance with audits and inspections.

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Develop skills in clinical trial design, understanding the roles and responsibilities of all parties involved, and managing investigational medicinal products.

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Ensure patient safety and data integrity through robust informed consent processes and effective adverse event reporting.

Why VIARES?

✓ Globally accredited & industry recognized
✓ Join 9,000+ members worldwide
✓ Making you the best candidate for the job
✓ All the tools you need to level up your career

Program structure

Explore the full curriculum in pdf and receive email reminders when enrollment closes:

Medicines Development Process, Good Clinical PracticeBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours
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build a strong foundation in the clinical research field

This first module will help you build a strong foundation in the clinical research field. You’ll explore the key stages of medicines development, from research and discovery to clinical trials and regulatory submissions. Additionally, you’ll master the principles of Good Clinical Practice (GCP) to ensure patient safety and data integrity throughout your research.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the background of medicines development and its critical processes.

✓ Learn about the research and discovery stages, and how product development progresses.

✓ Explore the phases of clinical development and their significance.

✓ Gain insights into regulatory submission, Health Technology Assessment, and lifecycle management.

✓ Master ICH GCP and other applicable regulations essential for clinical research.

Your instructor:

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KHILNA SAMAT

Meet Khilna Samat, a biochemistry major with a passion to connect top talent with opportunities. With experience working at a clinical trials site in the U.S., she has managed phase II-IV clinical trials across multiple therapeutic areas as a skilled Clinical Research Coordinator and played a pivotal role in improving and standardizing the study start-up process at the site as a Study Start-Up Specialist.

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MASTER THE REGULATORY LANDSCAPE OF CLINICAL RESEARCH

In this module, you’ll dive into the intricate regulatory environments of the EU and USA. You’ll gain an in-depth understanding of the national and international regulatory requirements, including ICH GCP E6 (R2), and learn the importance of compliance in your professional work. This module will equip you with the necessary skills to handle audits, inspections, and to develop robust quality assurance systems.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the significance of regulatory requirements in clinical research.

Learn about the regulatory systems in the USA and EU.

Master the monitor’s role in audits and inspections.

Recognize and deal with misconduct and suspected fraud.

Develop skills required before, during, and after inspections/audits.

Your instructor:

Gabrielle Disselhoff VIARES Clinical Research Associate Training

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

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DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

This comprehensive module provides an in-depth understanding of clinical trial design and the various roles and responsibilities within clinical research. You’ll delve into the critical components of a study protocol, explore diverse trial design methodologies, and gain insights into the ethical and regulatory frameworks that govern clinical research. Learn from expert Eric Klaver and master the skills necessary to ensure the integrity and success of your clinical trials.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the design features of a clinical trial.

Describe the rationale of complying with any given study protocol to protect patient rights and ensure data integrity.

Learn the roles and responsibilities of each key party in clinical research activities.

Your instructor:

Gabrielle Disselhoff VIARES Clinical Research Associate Training

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

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ENSURE PATIENT SAFETY AND MANAGE ADVERSE EVENTS

This module focuses on securing patient safety and handling adverse events in clinical trials. You’ll gain a thorough understanding of the informed consent process, adverse event identification and reporting, and strategies to protect patient confidentiality and data integrity. These skills are essential for maintaining ethical standards and compliance in clinical research.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Know how to encourage investigator sites to conduct patient recruitment ethically.

✓ Verify that the informed consent process has been properly performed and documented.

✓ Understand factors affecting patient safety and data integrity at investigator sites.

✓ Comprehend adverse event reporting requirements.

Your instructor:

Gabrielle Disselhoff VIARES Clinical Research Associate Training

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

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MASTER THE MANAGEMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS

This module covers the comprehensive management of investigational medicinal products (IP). You will learn about drug accountability, storage, dispensing, and documentation. The module also addresses randomization and blinding procedures, ensuring compliance with protocols, and FDA inspection findings. These skills are critical for maintaining the integrity and safety of clinical trials.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the key aspects of investigational product management.

✓ Learn the responsibilities of the Sponsor, Monitor, and Investigator.

✓ Conduct IP reconciliation at the end of the trial.

✓ Understand randomization and blinding processes.

✓ Monitor IP-related aspects during visits (drug accountability, storage conditions, etc.).

✓ Familiarize with common findings from FDA inspections.

Your instructor:

Gabrielle Disselhoff VIARES Clinical Research Associate Training

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

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comprehensive introduction to the start-up phase of clinical research

This module provides a comprehensive introduction to the start-up phase of clinical research, focusing on the EU Directive 2001/20/EC. You will delve into the key terminology, structures, and responsibilities involved in Study Start-Up (SSU), gaining insights into the regulatory framework that governs clinical trials in the European Union. This foundational knowledge is crucial for ensuring compliance and efficient project management in clinical research.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Get to know SSU nomenclature and its significance in clinical research.

Understand the main aspects of EU Directive 2001/20/EC that affect clinical trials.

Identify the primary responsibilities in the project cycle of SSU specialists.

Gain insights into the SSU structure and its role in clinical research projects.

Your instructor:

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BARTEK JAROSZ

18 years experience 

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STREAMLINE YOUR DOCUMENTATION PROCESS

This module will guide you through the complexities of submission documents in clinical research, focusing on both country and site-level requirements. You’ll learn how to prepare, adapt, and translate necessary documents to meet regulatory standards and ensure smooth submissions across various jurisdictions.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the main groups of submission documents.
Describe the documents in each group.
Identify general responsibilities for submission documents development.
Determine documents requiring country adaptation.
Identify documents requiring translation.
Review IMP labels per Annex 13 requirements.

Your instructor:

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BARTEK JAROSZ

18 years experience 

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MASTER THE IP RELEASE DOCUMENT REQUIREMENTS

Dive into the critical aspects of IP release documentation in clinical research. This module is designed to provide a comprehensive understanding of the essential documents, responsibilities, and timelines involved in the IP release process. You’ll learn about the intricate details of regulatory compliance and the differences between FDA and EU regulations.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the essential documents required for IP release.

Identify the timelines for preparing the IP release pack.

Describe the necessary documents for IP release.

Explain the country-level requirements for FDA 1572 signature/collection.

Differentiate between FDA requirements and EU regulations.

Your instructor:

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BARTEK JAROSZ

18 years experience 

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ENSURE SUCCESSFUL PROJECT COMPLETION

This comprehensive module is designed to equip you with the essential skills needed to effectively close and evaluate clinical research projects. You’ll gain in-depth knowledge on avoiding project drift, setting completion criteria, leading close-out meetings, and conducting thorough post-project evaluations. By mastering these aspects, you’ll ensure that your projects are completed successfully and yield valuable insights for future research endeavors.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Avoid project drift by proper planning, strong management, and clear communication.

Set project completion criteria and produce an adequate Project Acceptance Checklist.

Lead the close-out meeting with confidence and precision.

Evaluate the project – understand what went well, what went wrong, and derive lessons learnt.

Your instructor:

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KAMILA NOVAK

25+ years experience 

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Understanding and managing stakeholders is crucial in clinical research

This module will equip you with the skills to identify, analyze, and effectively communicate with stakeholders. You will learn how to tailor your communication strategies to different stakeholder needs, ensuring successful project outcomes.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

Understand the stakeholder landscape.
Analyze stakeholders effectively.
Identify key stakeholders.
Communicate successfully with different stakeholders, choosing the appropriate style, frequency, and level of detail.

Your instructor:

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KAMILA NOVAK

25+ years experience 

This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.

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Online Self-paced
learn at your own schedule and pace

Duration: 80 hours
Study 3 hours a week to finish in 6 months
10 modules + official certificate
testing through quizzes + exams

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You can test your knowledge with our free micro-certificates, that cover some of the most important topics in clinical research.
This way you can test the learning environment before buying!

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6 months access to the Clinical Operations Specialist course
Original price was: € 39,90.Current price is: € 19,90.

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Original price was: € 499,90.Current price is: € 299,90.

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5 Day Money-back Guarantee!

We pride ourselves on high-quality programs. That’s why we offer a 5-day no-questions-asked 100% money-back guarantee. If for any reason you are unhappy, you will get a full refund.

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What VIARES members get

Your membership to VIARES includes everything you need to excel in your clinical research career.

Worldwide LinkedIn community

Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.

Comprehensive Resource Library

Access a vast collection of templates, tools, and playbooks to enhance your clinical research work.
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Career center

Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.

Easy Learning Portal

Enjoy a user-friendly platform that makes accessing course materials and resources straightforward and convenient.
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Accredited Courses

Develop the latest and most in-demand clinical research skills with 100% online and globally recognized courses.

 

VIARES is known by the world’s leading organizations for for clinical reasearch providing you with the best training for your future dream job!

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Job Support

With VIARES you also get support with finding your clinical research dream job.

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Grow your career

VIARES’ digital certificates are a proven way to showcase that you mastered a new skill and upgrade your resume to land your next dream job.

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FAQ

Need help making the right choice?

Send our admissions advisors a message.

There are several reasons why you might want to consider becoming a clinical operations specialist:

  • Contributing to improving healthcare: As a clinical operations specialist, you will play an important role in managing clinical trials and ensuring that they are conducted safely, efficiently, and ethically. By doing so, you will be contributing to the development of new treatments and therapies that can ultimately improve the health and well-being of patients.
  • Career growth opportunities: Clinical operations is a growing field, and there is a high demand for professionals with expertise in this area. By becoming a clinical operations specialist, you can expect to have a wide range of career growth opportunities, including the potential to move into leadership roles.
  • Competitive compensation: Due to the demand for clinical operations specialists, many employers offer competitive compensation packages, including salaries, benefits, and opportunities for bonuses and other incentives. The salary of a clinical operations specialist can vary depending on a variety of factors, such as level of education and experience, location, and the specific industry or organization that employs them. According to the job search website Glassdoor, the average base salary for a clinical operations specialist in the United States is around $79,000 per year, with a range of approximately $54,000 to $119,000 per year. However, salaries can be higher in certain industries, such as biotechnology or pharmaceuticals, where the demand for clinical operations specialists is particularly high.
  • Variety of work: Clinical operations specialists work on a variety of tasks, including project management, study design, data management, and regulatory compliance. This variety of work can help keep your job interesting and challenging.
  • Flexibility: Clinical operations specialists may work in a variety of settings, including academic research institutions, government agencies, and private industry. This flexibility can allow you to find a work environment that best suits your interests and goals.

The responsibilities of a clinical operations specialist can vary depending on the specific organization or industry in which they work. However, some common responsibilities of a clinical operations specialist may include:

  • Designing and implementing clinical trials: Clinical operations specialists may be involved in designing and implementing clinical trials that are safe, efficient, and ethically sound.
  • Managing study timelines and budgets: Clinical operations specialists may be involved in creating and managing study timelines and budgets to ensure that trials are completed on time and within budget.
  • Monitoring study progress: Clinical operations specialists may monitor study progress to ensure that trials are being conducted according to protocol, regulatory requirements, and industry standards.
  • Coordinating with cross-functional teams: Clinical operations specialists may work closely with cross-functional teams, including data management, biostatistics, medical writing, and clinical sites to ensure the smooth execution of clinical trials.
  • Ensuring regulatory compliance: Clinical operations specialists may be involved in ensuring clinical trials are compliant with relevant regulatory requirements, such as those set forth by the FDA or other regulatory agencies.
  • Conducting risk assessments: Clinical operations specialists may be involved in assessing and managing risks associated with clinical trials to ensure patient safety and regulatory compliance.
  • Maintaining study documentation: Clinical operations specialists may be responsible for maintaining study documentation, including study protocols, informed consent forms, and study reports.
  • Overseeing site selection and management: Clinical operations specialists may be involved in the selection and management of clinical trial sites, including identifying and qualifying potential sites, and ensuring that they have the necessary resources and support to conduct the trial.

 

Overall, clinical operations specialists play a critical role in the successful execution of clinical trials, helping to ensure that new treatments and therapies can be developed and brought to market in a safe and efficient manner.

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.

No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).

To become a clinical operations specialist, you will typically need to have a strong educational background in a relevant field and relevant work experience. Here are some common educational and professional backgrounds that can prepare you for a career as a clinical operations specialist:

  • Bachelor’s degree in a relevant field: A bachelor’s degree in a relevant field, such as life sciences, nursing, or healthcare management, can provide a good foundation for a career in clinical operations. Relevant coursework may include clinical trial design, regulatory compliance, and clinical data management.
  • Work experience in clinical research: Clinical operations specialists typically have first experience working in clinical research, either in a research site, pharmaceutical company or in a CRO (Contract Research Organization). Experience in project management, study coordination, or data management are particularly relevant.
  • Certifications: Some clinical operations specialists may choose to pursue professional certifications in relevant areas such as clinical research, clinical operations, and project management. 

 

Overall, a combination of education, work experience, and professional certifications can help prepare you for a successful career as a clinical operations specialist.

What alumni say about this program

Based on 257 reviews
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VIARES ACADEMY ALL-In-One

Excellent

Clinical Research Associate

The course is amazing journey into clinical research career attainment with deep insights of course units that are enriching ,from which knowledge and skills are drawn from , the course contents so far are rich and contributive to career progress.

very informative

very user friendly and lots of information to gather. Thank you

Clinical Study Coordinator Academy

Course content

Very rich course content.

Excellent

I want to say a big thank you to all VIARES Coordinators, for a well packaged program. It is so easy to understand a well-organized. I have just completed the Clinical Research Associate, it was awesome. I will recommend it to friends.

C
VIARES ACADEMY ALL-In-One
Ciprian Matcovici

VIARES ACADEMY ALL-In-One

Fabulous and super powered

The CTA was very informative and had a wide topics covered. I am a fresher to the field but now with the knowledge imparted by all the professionals, I feel empowered, Thank you all. Looking forward to complete the other courses in the All in One Academy, Thank you Viares Team

A
Clinical Research Associate Academy
Anthony Abudu
VIARES ASSESSMENT REVIEW

So far my journey here to become a CRA has been so insightful and impactful. I look forward to more exciting topics and lectures as far as the CRA program is concerned.

V
VIARES ACADEMY ALL-In-One
Vincent Alushula
Straight forward course

Very informative yet user friendly

Great information

My only critique is with the navigation. When you finish one module it should have an arrow to go to menu of next module The course content is great and informative

N
Clinical Trials Assistant Academy
Nhlamulo Wendy Baloyi

Clinical Trials Assistant Academy

Trial Master File Specialist

I want to say a big thank you to all the instructors and VIARES Academy for the great privilege to this unique ,easy to understand and accessible program. You'll have contributed immensely to my life. Good job

M
VIARES ACADEMY ALL-In-One
Maria Vilas Eiroa

VIARES ACADEMY ALL-In-One

Insightful

Alot of content relevant to my area of work.

R
Clinical Research Associate Academy
Regina Akise

Clinical Research Associate Academy

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.

N
Clinical Research Associate Academy
Nasson Chibwana
Very informative

The course structure is very simple to follow and above all the topics are taught by experts in the field.

Clinical Trials Assistant Academy

V
Clinical Research Associate Academy
Vincent Alushula
Mr Vincent

Awesome Self explanatory course. User friendly and easy to navigate and work it out. A love the fact that it keeps tabs with previous topic location.

Excellent

Excellent value for money

So far this has been a great purchase. I have completed two of the courses and am working on a third.

K
VIARES ACADEMY ALL-In-One
Karima Oumalk

VIARES ACADEMY ALL-In-One

Excellent CRA course

It is well explained and easy to understand , It opened my eyes to the highly new research world.

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