286 reviews

Clinical Operations Specialist

Name: Clinical Operations Specialist
Price: 16.9 USD
Availability: InStock
Rating: 4.88 (286 reviews)

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

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

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

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

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

Read our 286 verified reviews

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

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:

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.

Regulatory Environment in the EU and USABEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

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:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Clinical Trial Design & Clinical Research Roles and ResponsibilitiesBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 9 hours

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:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Patient Protection & Adverse Events BEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

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:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Investigational Medicinal Product Management BEGINNER
1 lesson • 1 assignment • 1 knowledge check • 8 hours

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:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Introduction to Start Up and the EU DirectiveBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

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:

BARTEK JAROSZ

18 years experience

Country and site level submission documents, adaptation and translationBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

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:

BARTEK JAROSZ

18 years experience

IP release document requirementsBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

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:

BARTEK JAROSZ

18 years experience

Project Management BasicsBEGINNER
1 lesson • 1 assignment • 1 knowledge check • 10 hours

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:

KAMILA NOVAK

25+ years experience

Stakeholder ManagementBEGINNER
1 lesson • 1 assignment • 1 knowledge check • 10 hours

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:

KAMILA NOVAK

25+ years experience

Certification Exam
Exam • 2 hours

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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learn at your own schedule and pace

38 learning activities

e-learnings, assignments, quizzes

10 modules + official certificate

testing through quizzes + exams

Get free access to our learning portal and experience it yourself

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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4.88 based on 286 reviews

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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.

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.

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.

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!

Job Support

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

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

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Why should I enrol in this Clinical Operations Specialist course?

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.

What are the typical responsibilities of a Clinical Operations Specialist?

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.

What is the 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.

Is there a fixed schedule?

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).

Is this program the right fit for me?

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

Clinical study coordinator

Thr course has a fun way of learning. It allows one to grasp content easily. I am recommending it to my friends.

Clinical Research Associate

CRA

the modules are very informative

Excellent...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!"

Overall, 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.

Excellent

Excellent

The content of the course is very informative and insightful...I WILL LOVE TO TAKE THE Start up specialist soon.I will highly recommend it to my colleagues.

VIARES Micro Certificate PHASES OF CLINICAL TRIALS

Clinical Operations Specialist

This was an incredible course that provided important insight to the operational aspects of the regulatory process.

Clinical Study Coordinator I

Clinical Research Associate

VIARES Clinical Research Associate Academy

N/A

Medicine development process and the Regulatory requirements compliance and Quality Assurance Audits and Inspection.

Clinical Research Associate

The 'All in One' order process was easy, accessing materials is straightforward, and content is informative. On-demand access is very convenient for completion.

Clinical trial assistant

I would like to pass it but this days I’m so busy and I don’t have enough time to progress with it

Exceptional

The course is very detailed for its length and gives exactly what one may need to navigate the clinical research landscape and medical science.

VIARES Micro Certificate DATA ANALYSIS

Very informative

Detailed information

Clinical Research Associate Academy

Great learning platform

VIARES is an amazing learning platform. After completing the Clinical Research Associate program, I feel well equipped to take on the role and responsibilities of a CRA with great confidence. I would definitely recommend it!

VIARES Micro Certificate PHASES OF CLINICAL TRIALS

Clinical Research Associate

Great

I have been doing the CRA course for about a month now and so far I am really enjoying it. The lectures are really easy to follow, interesting and informative. I'm looking forward to learning more.

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Clinical Operations Specialist

What you will learn

Why VIARES?

Program structure

build a strong foundation in the clinical research field

Your instructor:

MASTER THE REGULATORY LANDSCAPE OF CLINICAL RESEARCH

Your instructor:

DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

Your instructor:

ENSURE PATIENT SAFETY AND MANAGE ADVERSE EVENTS

Your instructor:

MASTER THE MANAGEMENT OF INVESTIGATIONAL MEDICINAL PRODUCTS

Your instructor:

comprehensive introduction to the start-up phase of clinical research

Your instructor:

STREAMLINE YOUR DOCUMENTATION PROCESS

Your instructor:

MASTER THE IP RELEASE DOCUMENT REQUIREMENTS

Your instructor:

ENSURE SUCCESSFUL PROJECT COMPLETION

Your instructor:

Understanding and managing stakeholders is crucial in clinical research

Your instructor:

Get free access to our learning portal and experience it yourself

Enrollment Closes In:

Foundation Access

Accelerator Access

Premium Access

1 Year Access 12 installment payments

1 Year Access 1 payment

Lifetime Access 1 payment

5 Day Money-back Guarantee!

What VIARES members get

Worldwide LinkedIn community

Comprehensive Resource Library

Career center

Easy Learning Portal

Accredited Courses

Job Support

Grow your career

FAQ

What alumni say about this program

Related Clinical Research Programs

VIARES ACADEMY ALL-In-One

Clinical Research Associate

Navigating ICH GCP E6(R3)

Clinical Research Project Manager

Clinical Study Coordinator I

Study Start Up Specialist

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