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Clinical Research Project 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 Research Project Specialist or similar.

What you will learn

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Acquire comprehensive knowledge of the medicines development process, from initial discovery to lifecycle management, including regulatory submissions.

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Understand and apply ICH GCP guidelines, and navigate the complex regulatory environments in the EU and USA, ensuring compliance in clinical research activities.

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Gain expertise in designing clinical trials, managing investigational medicinal products, and understanding the roles and responsibilities of various stakeholders in clinical research.

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Master the principles of patient protection, informed consent, and adverse event reporting to ensure patient safety and data integrity throughout clinical trials.

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

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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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 

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essential skills to conceive and define successful projects

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.

Your instructor:

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KAMILA NOVAK

25+ years experience 

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MASTER THE ART OF PROJECT RISK MANAGEMENT

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.

Your instructor:

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KAMILA NOVAK

25+ years experience 

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BUILD YOUR EXPERTISE IN CLINICAL RISK MANAGEMENT

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.

Your instructor:

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KAMILA NOVAK

25+ years experience 

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PLAN YOUR CLINICAL RESEARCH PROJECTS EFFECTIVELY

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.

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.

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

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Online Self-paced
learn at your own schedule and pace

Duration: 100 hours
Study 4 hours a week to finish in 6 months
10 modules + official certificate
testing through quizzes + exams

Get free access to our learning portal and experience it yourself

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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 Research Project Specialist course
Original price was: € 39,90.Current price is: € 19,90.

monthly for 6 months

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

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4.89 based on 257 reviews

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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.

Study Start Up Specialist online course clinical research
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SUPPORT

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 project specialist:

  • Rewarding work: As a clinical project specialist, you would be responsible for overseeing clinical trials and ensuring that they are conducted according to established protocols and guidelines. This work can be incredibly rewarding, as you would be playing an important role in helping to develop new treatments and cures for various health conditions.
  • High demand: The field of clinical research is growing, and there is an increasing demand for skilled clinical project specialists. This means that there are likely to be many job opportunities available to you if you choose to pursue this career.
  • Competitive salary: Clinical project specialists are typically well-paid, with a median annual salary of around $86,000 according to Payscale. However, it’s important to note that these figures are only a general guideline and may not reflect the specific salary that you would earn in your particular situation. Your salary may be influenced by factors such as the size and type of organization you work for, your level of experience, the type of clinical research you specialize in, and the geographic location of your employer.
  • Career growth: As you gain experience and expertise in the field, there may be opportunities for career advancement, such as moving into a leadership role or specializing in a particular area of clinical research.
  • Variety of work: Clinical project specialists work with a variety of stakeholders, including clinical investigators, study coordinators, and regulatory agencies. This can provide a diverse and interesting work experience.
 

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:

  • Developing and implementing study protocols: Clinical project specialists are responsible for developing and implementing study protocols that outline the procedures, timelines, and requirements for conducting clinical trials.
  • Managing study timelines and budgets: Clinical project specialists are responsible for ensuring that clinical trials are completed on time and within budget. This includes managing study milestones and coordinating activities among study team members.
  • Recruiting and selecting study participants: Clinical project specialists may be involved in recruiting and selecting study participants, and ensuring that they meet eligibility criteria and are properly informed about the study.
  • Overseeing study conduct: Clinical project specialists are responsible for overseeing the conduct of clinical trials to ensure that they are conducted in compliance with relevant regulations and guidelines.
  • Analyzing study data: Clinical project specialists may be involved in analyzing study data and preparing reports for regulatory authorities, study sponsors, or other stakeholders.
  • Communicating with study team members and stakeholders: Clinical project specialists are often responsible for communicating with study team members and stakeholders, such as study sponsors, regulatory agencies, and ethics committees.
  • Ensuring safety and ethical standards: Clinical project specialists are responsible for ensuring that clinical trials are conducted in a safe and ethical manner, with particular attention to protecting the rights and safety of study participants.

 

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:

  • 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 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:

  • A bachelor’s degree in a relevant field: Many employers prefer clinical project specialists to have a bachelor’s degree in a relevant field, such as clinical research, biology, pharmacology, or a related discipline.
  • Experience in clinical research: Clinical project specialists typically need to have experience in clinical research, either as a clinical trials associate (CTA), study coordinator, or in another related role. This experience can provide a strong foundation in the principles and practices of clinical research, and can help you develop the skills and expertise needed for a career as a clinical project specialist.
  • Knowledge of regulations and guidelines: Clinical project specialists need to have a thorough understanding of the regulations and guidelines that govern clinical research, including FDA/EMA regulations, ICH guidelines, and GCP guidelines.
  • Strong communication and project management skills: Clinical project specialists need to be effective communicators and project managers, with the ability to coordinate and manage complex projects involving multiple stakeholders.
 

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.

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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