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Study Start Up Specialist – Enterprise

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.

COURSE Content

Successfully complete the 9 competency modules below to obtain your VIARES Study Start Up Specialist Certificate.
  • Background of medicines development
  • Research and discovery stage & product development
  • Clinical development
  • Regulatory submission, Health Technology Assessment, lifecycle management
  • ICH GCP and other applicable regulations
  • Applicable international and national regulations
  • ICH GCP E6 (R2)
  • FDA Regulation
  • Quality Assurance: Audits and Inspections
  • The Study Protocol
    • Elements of a Study Protocol according to ICH GCP
    • Trial Design
    • Methodologies
  • Roles and Responsibilities
    • Ethics Committees
    • Sponsor / Monitor
    • Investigator
    • Competent Authority
  • SSU structure, responsibilities and involvement in project life-cycle
  • Main groups of core study submission documents
  • Core documents required for submissions
  • Documents development responsibilities
  • Core submission package
  • Critical path for efficient start up
  • Country level documents for submission
  • Country documents development responsibilities
  • Country adaptations
  • ICFs / Assents requirements, adaptation and GDPR
  • Labels
  • Translation requirements
  • Site level documents
  • Country submission packages
  • VHP process and timeliness
  • VHP submission process vs. regular country submission process – differences
  • VHP advantages and disadvantages
  • Upcoming regulations
  • Protocol Amendments in VHP
  • Main regulatory bodies and their responsibilities
  • Submission strategies and dependencies (main groups on diagrams)
  • Submissions and approval timelines
  • Comments, conditional approvals, rejections
  • EudraCT study registry
  • EudraCT GMP database
  • EudraCT Annex 1
  • EudraCT Annex 2
  • EoT notification form
  • Upcoming EU regulation
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing


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.

Getting a clinical study start-up specialist certificate can be beneficial for several reasons, including:

Enhancing your knowledge and skills: A certificate program can provide you with specialized knowledge and training in clinical study start-up, which can help you better understand the complex regulatory and operational requirements of this role.

Advancing your career: Obtaining a certificate can help you demonstrate your expertise and commitment to the field of clinical research, making you a more competitive candidate for job opportunities and career advancement.

Meeting industry standards: Many organizations and employers may require or prefer candidates who have a clinical study start-up specialist certificate to ensure that their employees meet industry standards and have the necessary skills and knowledge.

Staying up-to-date: Certificate programs often include ongoing education and training, which can help you stay current with the latest regulatory requirements, best practices, and technologies in the field of clinical study start-up.

Overall, obtaining a clinical study start-up specialist certificate can be a valuable investment in your career and can help you develop the skills and knowledge needed to succeed in this field.

Hear from our graduates


The VIARES Academy is one of the most valuable training experiences I’ve had in my career as a clinical researcher. The streamlined course content, challenging homework assignments, and live instruction create a training format


that I found engaging, thorough, and dynamic. As a result of completing this program, I feel much more prepared to succeed as a clinical research associate.




The VIARES CTA Academy is a great resource for those interested in entering the field of clinical research. It provides you with valuable knowledge on multiple topics such as data management, key roles in clinical research, the drug development


process, and important documentation. After my completion of the VIARES CTA academy, I am confident in my knowledge of the clinical process.


reviews curated by

WHY BECOME A Study Start Up Specialist?

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 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.


To become a study start-up specialist you should meet some general requirements.

A bachelor’s degree in a related field, such as life sciences, health sciences, or a related discipline, is typically required. Some organizations may prefer or require a master’s degree in a relevant field. Most organizations prefer candidates who have some experience working in clinical research, such as in a clinical trial coordinator or clinical trials assistant (CTA) role. A good understanding of the regulatory requirements and guidelines governing clinical research is essential. This includes knowledge of Good Clinical Practice (GCP) guidelines and other relevant regulations. Strong organizational skills, attention to detail, and communication skills are crucial for success in this role. Candidates should also be comfortable working with stakeholders from a variety of backgrounds, such as investigators, regulatory agencies, and study sponsors.

Overall, a combination of education, experience, knowledge, skills, and certifications can help you become a competitive candidate for a study start-up specialist role.

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 and we will contact you.


Study Start Up Specialist – Enterprise


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12 SMALL INSTALLMENTS paid monthly over one year
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  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system


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  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included​
  • All online-training course material
  • Online access to our learning management system


Pay in 12 monthly INSTALLMENTS
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  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
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