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.

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
  • VHP PLUS
  • 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

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.

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.

Delivered by industry experts

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BARTEK JAROSZ

Study Start Up Guru

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Gabi Disselhoff

Regulatory & Quality Expert

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Eric Klaver

Clinical Operations Expert

Hear from our graduates

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Hussein

After finishing my PhD in Developmental Biology, I wanted to enter the clinical research field. I have done the CRA course and it was super beneficial. I enjoyed the micro courses and assignments. Thanks to VIARES Academy, I also got an

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ACRP ELKA certificate and I am sure it would be a great push for me to find an entry level job. Thank you VIARES Academy.

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Jun

The VIARES Clinical Research Academy program is a great opportunity to build the clinical research skills for not only CRAs but also every role involved in clinical research. As a physician, I have participated in several clinical trials in Asia in the role of

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personnel of investigator team. This structured and well-developed program has helped me to gain and refresh my professional knowledge in clinical research, especially the regulatory environment in the EU and USA. After graduating from this program, I am more confident in my professional career and believe I will be competent in other roles of clinical research as well. Many thanks to the VIARES team and all the tutors.

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Customer Reviews

Based on 9 reviews
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J
Johannes Mashaba
Great Course

This is a great course and very helpful. It is 100% relevant.

Please add a Regulatory Affairs courses too.

N
NolwazI Mahlangu

Great.

J
Jodie

I found the VIARES Study Start Up Specialist program extremely informative and educational. Not only has my understanding of study start up developed exponentially, but it has also made me feel so much more confident in my work. I’d highlyrecommend the program to anyone who wishes to learn more about study start up!

A
Andres Lannepoudenx
Good

It Is very good, well explained and contents organized. I am working for nine months in an important CRO in the SSU departament and I found this training very useful, like the CRA one I did before with you.
Unfortunatly, due to my workload, I cant enter more often to finish ir More quikly.
Best regards

N
Nassim

Many thanks to the supportive team at VIARES academy for providing a well-organized and thorough training. The course content was very informative, comprehensive and very well presented. It was a wonderful experience and made mefeel more confident to pursue a career in Clinical Research.

reviews curated by judge.me

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.

IS THIS THE BEST OPTION FOR ME?

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 academy@viares.com and we will contact you.

NEW JOBS POSTED TODAY

This is a snapshot of the latest new entries from our full list of global clinical research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs. Get full access with a VIARES account.

 
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BESTSELLER

Study Start Up Specialist
Typical annual market salary:
$52,000 to $105,000+
This Course includes

 674,90

 112,90 / month for 12 monthsPay monthly

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BARTEK JAROSZ

18 Years experience

Bartek has 18 years experience in clinical research business, mostly spent at largest global Contract Research Organizations. At Quintiles he was responsible for pioneer development of clinical start-up and regional contract departments. He served as executive member of clinical start-up leadership team at INC Research, acting as global head of site contract division. His most recent experience includes support for pharmaceutical organizations in various project specific roles. Bartek enables biopharma to get their sites up and running faster. He is author of several training programs about site contract related matters and successfully delivered to hundreds of individuals worldwide.

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1 YEAR ACCESS
Pay in 12 monthly INSTALLMENTS
  • One year access to your training courses
  • Plan ends automatically after 12 payments
  • Personalized certificate upon completion
  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
  • No training course handouts for offline learning
  • No unlimited access

LIFETIME

one payment - unlimited access
ONLY ONE Payment
  • All benefits from the montly payment plan
  • Life-time access to your purchased course
  • Training course handouts included
  • Life-time support from the VIARES tutors
  • And much more...
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  • VIARES exam – 2 attempts included
  • All online-training course material
  • Online access to our learning management system
  • Personalized certificate upon completion

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one payment - unlimited access
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  • All benefits from the monthly payment plan
  • Life-time access to your purchased course
  • Life-time support from the VIARES team
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