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.

We train and certify you

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

The VIARES Certification is an online exam covering 100 questions from the VIARES training course. You need to complete the exam within 90 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

Requirements

This program will be of benefit to anyone with a life science degree and first relevant work experience, ideally but not necessary in clinical research or related areas.

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.

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.

A Flexible Online Setup

Our setup enables you to complete this program either next to a full-time job or in a focused effort. 100% of the program is online and most of the training courses can be completed at any time.

You can start the training right away and complete it at your own pace. This training contains 100 hours of online material.
You do not need to wait for a kick-off date, you can start your training anytime  – as early as today if you wish.

Get Certified & Job Ready

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, In-House Clinical Research Associate or similar.

The VIARES Study Start Up Specialist program is more than just a training. It’s a life-changer!

Certificates:

  • VIARES, GCP

 

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • join career events at no cost
  • free access to our weekly updated global job list
  • apply to exclusive job offers
  • get your personal career coaching
  • any time free cancellation of monthly payment

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.

WHY GET A CERTIFICATION?

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.

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.

Position – click to go to jobCompanyLocationDate CreatedSourceTitleId (key)
Position – click to go to jobCompanyLocationDate CreatedSourceTitleId (key)

Your expert instructors

Hear from our graduates

Plamena

Plamena

I passed the final exam of Clinical Research Talent Program by VIARES and I`m proud of it! I learned a lot of this interesting course from different experts in this field. I`m happy that I got the opportunity to participate in the CRA program.

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Thank you VIARES!

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Goldy

Goldy

I have successfully completed the VIARES Clinical Research Talent Program, allowing me to expand my clinical research skills. The program has informative micro-courses and webinars which are organized. This program provided me with deep

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insights into clinical research. I highly recommend it to anyone interested in the field of Clinical Research.

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Customer Reviews

Based on 3 reviews
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A
Anita Bloemink
Study start up specialist

Thoroughly enjoying the course! User friendly videos, helpful assignments, and challenging tests. I wasn’t expecting to have to pay for notes but I’m making my own notes as I go. I’ll probably buy the notes at the end of the month. All good! Very interesting and valuable!

H
Humberto Salazar Angulo
Amazing

The information is very helpful. And everything is organized. I need your support. I need to send again an assignment. Could you please help me with that?

D
Daphne Reason

Hello,

I like the course very user friendly, I'm learn things that I didn't know and getting a refresher on things that I had forgetting. Also, I have submitted two assignment but I don't see a grade for them. I have also recommend a few colleague to take a few of the courses. Thank you.

reviews curated by judge.me

 

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Study Start Up Specialist
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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.

      ERIC KLAVER

      Trained in 6 continents

      Eric brings with him 20 years of experience training and meeting management and has worked in clinical research for almost 25 years. The global reach of this experience (Eric has trained in six continents) makes him the partner of choice to work with. Eric combines soft skills with personal responsibility in every training.

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