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.
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.
Explore the full curriculum in pdf and receive email reminders when enrollment closes:
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.
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.
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.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
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.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
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.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
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.
GABI DISSELHOFF
Regulatory & Quality expert
38 years in pharmaceutical development
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.
BARTEK JAROSZ
18 years experience
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.
BARTEK JAROSZ
18 years experience
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.
BARTEK JAROSZ
18 years experience
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.
KAMILA NOVAK
25+ years experience
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.
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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There are several reasons why you might want to consider becoming 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:
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:
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:
Overall, a combination of education, work experience, and professional certifications can help prepare you for a successful career as a clinical operations specialist.
Clinical Operations Specialist
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Verified ownerReally good work and presentations. I wish live also be a part of it. Otherwise the course is excellent
Verified ownerVIARES ACADEMY ALL-In-One Accelerator
Verified ownerClinical Research Associate Accelerator
Verified ownerClinical Research Associate
Verified ownerClinical Study Coordinator II
Verified ownerVIARES Micro Certificate DOUBLE-BLIND STUDY
Verified ownerCliniical Research associate Tutorials were very clear and tutors very friendly. Queries were responded to very promptly.
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
Verified ownerVIARES Micro Certificate PHASES OF CLINICAL TRIALS
