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.
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.
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.
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.
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
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
BARTEK JAROSZ
18 years experience
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.
BARTEK JAROSZ
18 years experience
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.
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 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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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.
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:
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.
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 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.
Study Start Up Specialist
| 5 star | 92% | |
| 4 star | 5% | |
| 3 star | 3% | |
| 2 star | 0% | |
| 1 star | 0% |
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
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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
