Study Start Up Specialist

Q: Is this program the right fit for me?

To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.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.

Become a Study Start-Up Specialist and master the processes that bring clinical trials to life. Learn key regulatory requirements, submission strategies, and project initiation skills to ensure compliance and efficient trial launches. Start building your expertise in clinical research today!

273 reviews

Study Start Up 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 Study Start Up Specialist or similar.

What you will learn

Acquire knowledge of the entire medicines development lifecycle, from the research and discovery stages to regulatory submissions and lifecycle management.

Learn essential ICH GCP guidelines and navigate regulatory requirements in the EU and USA, including compliance, audits, and inspections.

Gain skills in designing study protocols, understanding trial design methodologies, and recognizing the roles and responsibilities of clinical research professionals.

Master the key aspects of study start-up processes, including document submission requirements, voluntary harmonization procedures, and compliance with EU Directives.

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 273 verified reviews

Program structure

Medicines Development Process and Good Clinical Practice (GCP)BEGINNER
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

NAVIGATE THE COMPLEX WORLD OF REGULATORY REQUIREMENTS

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 • 8 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:

KHILNA SAMAT

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

Voluntary Harmonization Procedure process and Informed Consent Form / GDPRBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

in-depth exploration of the Voluntary Harmonization Procedure (VHP) and the General Data Protection Regulation (GDPR)

This module provides an in-depth exploration of the Voluntary Harmonization Procedure (VHP) and the General Data Protection Regulation (GDPR). You will gain an understanding of the VHP process, its benefits, and how it compares to regular submission processes. Additionally, you will learn about the essential elements of the Informed Consent Form (ICF) and the GDPR requirements that pertain to clinical research.

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

✓ Describe the VHP process benefits

✓ Compare VHP process to regular submission processes

✓ Identify the preferable submission strategy for different scenarios

✓ Explain VHP PLUS and its significance

✓ Understand the critical elements of the Patient Information Sheet (PIS) and Informed Consent Form (ICF)

✓ Identify missing items in PIS and ICF

✓ Comprehend GDPR requirements related to ICF

Your instructor:

BARTEK JAROSZ

18 years experience

Country regulatory bodies, submission strategies, timelinesBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

Navigate Country Regulatory in Clinical Research

This module provides an in-depth understanding of the roles and responsibilities of various country regulatory bodies, their submission strategies, and timelines. You will learn to navigate the complex landscape of regulatory submissions and approvals, equipping you with the knowledge to handle comments, conditional approvals, and rejections effectively.

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

✓ Understand the scope of responsibilities of different regulatory bodies.

✓ Learn about submission strategies and key dependencies.

✓ Explore approval timelines and potential challenges.

✓ Gain insights into handling conditional approvals and rejections.

Your instructor:

BARTEK JAROSZ

18 years experience

EudraCT and upcoming EU regulationsBEGINNER
2 lessons • 1 assignment • 1 knowledge check • 8 hours

navigating the EudraCT registry

This module will equip you with essential knowledge and skills for navigating the EudraCT registry and understanding upcoming EU regulations. You’ll delve into the intricacies of the EudraCT study registry and GMP database, learn how to manage Annex 1 and Annex 2 updates, and stay ahead of new regulatory submission processes. Led by expert instructor Bartek Jarosz, this module ensures you’re well-prepared for regulatory compliance in clinical research.

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

✓ Learn how to search the EudraCT registry and GMP database.
✓ Get to know EudraCT forms and their applications.
✓ Understand how to update Annex 1 and Annex 2 at the country level.
✓ Gain knowledge of the upcoming submission process in the EU.

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

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.

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

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Duration: 80 hours

Study 3 hours a week to finish in 6 months

9 modules + official certificate

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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.

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 Study Start Up Specialist course?

Becoming a study start-up specialist can be a rewarding career choice because it involves overseeing and managing the crucial early stages of clinical trials, ensuring they are initiated and executed properly. This can involve working with a variety of stakeholders, including investigators, regulatory agencies, and study sponsors, and requires a strong attention to detail, communication skills, and knowledge of relevant regulations and guidelines. Additionally, the field of clinical research is growing, and there is a high demand for qualified professionals in this area.

The salary of a study start-up specialist can vary depending on factors such as their level of experience, location, and the type of organization they work for. According to Glassdoor, the average base salary for a study start-up specialist in the United States is around $75,000 per year, with a range between $52,000 to $105,000. However, salaries can be higher for those with more experience or who work in certain industries or regions. It’s important to note that these figures are just estimates and may not reflect the exact salary of every individual in this role.

What are the typical responsibilities of a Study Start Up Specialist?

The responsibilities of a study start-up specialist can vary depending on the specific organization and the type of clinical trials they are involved in, but some typical responsibilities may include:

Planning and managing the start-up activities of clinical trials
Ensuring compliance with regulatory requirements and guidelines
Identifying and recruiting study sites and investigators
Coordinating with study sponsors and vendors to ensure timely initiation of trials
Preparing and submitting regulatory documents, such as informed consent forms and ethics committee applications
Coordinating with study monitors to ensure proper training and site initiation
Managing study budgets and timelines
Ensuring proper documentation and record-keeping throughout the study start-up process.

These are just a few examples of the typical responsibilities of a study start-up specialist. The exact duties can vary depending on the organization and the specific clinical trials involved.

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 CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.

In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.

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

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.

Clinical Trials Assistant Academy

Very Good

I really enjoyed the course. The content was well condensed to what is really important.

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.

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

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.

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Study Start Up Specialist

Average Market Salaries:
above $45,000 p.a.

Original price was: € 49,90.Current price is: € 9,90.

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Original price was: € 49,90.Current price is: € 9,90.

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Study Start Up Specialist

Study Start Up Specialist

What you will learn

Why VIARES?

Program structure

build a strong foundation in the clinical research field

Your instructor:

NAVIGATE THE COMPLEX WORLD OF REGULATORY REQUIREMENTS

Your instructor:

DESIGN YOUR CLINICAL RESEARCH STUDIES WITH PRECISION

Your instructor:

comprehensive introduction to the start-up phase of clinical research

Your instructor:

STREAMLINE YOUR DOCUMENTATION PROCESS

Your instructor:

in-depth exploration of the Voluntary Harmonization Procedure (VHP) and the General Data Protection Regulation (GDPR)

Your instructor:

Navigate Country Regulatory in Clinical Research

Your instructor:

navigating the EudraCT registry

Your instructor:

MASTER THE IP RELEASE DOCUMENT REQUIREMENTS

Your instructor:

Get free access to our learning portal and experience it yourself

Enrollment Closes In:

Single

Academy

All in One

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

Clinical Research Associate

Clinical Research Project Manager Academy

Clinical Study Coordinator I

Trial Master File Specialist

Clinical Operations Specialist

Clinical Research Project Specialist

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