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 Project Specialist or similar.
Acquire comprehensive knowledge of the medicines development process, from initial discovery to lifecycle management, including regulatory submissions.
Understand and apply ICH GCP guidelines, and navigate the complex regulatory environments in the EU and USA, ensuring compliance in clinical research activities.
Gain expertise in designing clinical trials, managing investigational medicinal products, and understanding the roles and responsibilities of various stakeholders in clinical research.
Master the principles of patient protection, informed consent, and adverse event reporting to ensure patient safety and data integrity throughout clinical trials.
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 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
You’ll dive into the strategic alignment of projects, the intricacies of project start-up, and the critical role of decision-making in project success. Learn to craft a comprehensive project definition that ensures clarity and stakeholder alignment from the outset.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the project external and internal environment.
✓ Assess how the environmental factors affect the project.
✓ Define requirements to make the project a success story.
✓ Outline the project scope.
✓ Build a strong project definition.
✓ Obtain approval for your project definition.
KAMILA NOVAK
25+ years experience
In this module, you will delve into the essentials of managing risks within clinical research projects. Gain a comprehensive understanding of risk management processes, learn to identify potential risks, and develop strategies to mitigate them effectively. Through this module, you will enhance your ability to ensure project success by proactively managing uncertainties and improving overall project outcomes.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand what constitutes a risk and the terminology used in risk management.
✓ Learn the risk management process and an overview of various tools.
✓ Identify project risks using a starter checklist.
✓ Develop a primary response strategy for risks.
✓ Analyze and quantify risks, calculating the Risk Priority Number.
✓ Monitor risks under different conditions.
✓ Assess the effectiveness of your risk management process.
✓ Draw lessons for process improvements.
KAMILA NOVAK
25+ years experience
This module will equip you with essential knowledge and skills to manage risks effectively in clinical research. You’ll delve into the regulatory framework, learn to apply risk management principles, and develop comprehensive risk management plans. Gain proficiency in using advanced tools and technology to mitigate risks, ensuring the success of clinical studies.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Understand the regulatory framework for risk management in clinical studies.
✓ Apply general risk management principles and procedures on clinical projects.
✓ Develop the Clinical Risk Management Plan.
✓ Use adequate tools to manage clinical study risks efficiently.
✓ Communicate effectively with functional teams to manage clinical study risks successfully.
KAMILA NOVAK
25+ years experience
This module equips you with the essential skills for project planning in clinical research. You’ll delve into the key stages of planning, identify critical gaps, and allocate responsibilities to ensure the successful delivery of your clinical studies. Mastering project planning is crucial for effective study execution, compliance, and budgeting.
Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.
✓ Identify the key stages of a project.
✓ Analyze gaps for a successful delivery.
✓ Plan strategies to bridge the gaps.
✓ Assign responsibilities to your team members.
✓ Develop a clinical study budget.
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 project specialist:
Ultimately, if you are passionate about helping to develop new treatments and cures, enjoy working in a fast-paced and dynamic environment, and want a career with good job prospects and competitive pay, then becoming a clinical project specialist may be a great option for you.
The specific responsibilities of a clinical project specialist can vary depending on the organization and the nature of the clinical research being conducted. However, some typical responsibilities of a clinical project specialist may include:
Overall, clinical project specialists play a key role in the planning, execution, and oversight of clinical trials. They work closely with a range of stakeholders, from study participants to regulatory authorities, to ensure that clinical trials are conducted in a safe and effective manner, and that the results are properly analyzed and reported.
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 project specialist, you typically need to have a background in clinical research, along with relevant education and experience. The specific qualifications and requirements can vary depending on the employer and the nature of the position, but some typical educational and experiential requirements include:
Overall, a strong background in clinical research, combined with relevant education and experience, can help you develop the skills and expertise needed to pursue a career as a clinical project specialist.
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 Project Specialist
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Verified ownerJust finished the VIARES CRA Academy and I’m blown away. Clear, practical, straight-to-the-point lessons that actually prepare you for the real job. Passed the exam first try. Best investment I’ve made in my career. Highly recommend!
Thank you VIARES
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
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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
