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Study Start Up Specialist
Content: Medicines Development Process, Good Clinical Practice, Regulatory Environment in the EU and USA, Clinical Trial Design & Clinical Research Roles and Responsibilities, Start Up and core submission documents, Country level documents for submission, VHP process and timeliness, EudraCT, IP release document requirements, …
Learning: 80-100 hours online and self-paced, 9 Modules, Final Exam
Certificates: GCP, VIARES
Prerequisites: ideally life science education and first work experience
Payment: Pay in 12 monthly installments or save with our optional 1-time payment.
It’s Not Just A Course
It’s A Self-Paced 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.
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 or similar.
The Get Cognitio Study Start Up Specialist program is more than just a training. It’s a life-changer!
The Training includes access to all Academy Services, and an industry recognized professional certification.
Access to all Academy Services
Modules including:
- e-learnings
- assignments
- knowledge checks
Industry Recognized Professional Certification
- Get Cognitio Certificate
- GCP Certification
5 Steps Guide to Get Your Dream Job
- Set clear goals
- Get properly trained
- CV, CV, CV
- Ace Your Interview
- Negotiate
Global Clinical Research Jobs
- Weekly New Global Jobs
- Skip the Application Line
- Join Career Events
Course Program
The Study Start Up Specialist program consists of nine modules. You will complete the following learning activities:
- Review the e-learning
- Submit the assignment
- Take the module test
- Take the final exam
9 Modules – 100 Learning Hours – 3 Certificates.
Successfully complete the 9 competency modules below to obtain your Get Cognitio Certificate.
Medicines Development Process, Good Clinical Practice
- 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
Regulatory Environment in the EU and USA
- Applicable international and national regulations
- ICH GCP E6 (R2)
- FDA Regulation
- Quality Assurance: Audits and Inspections
Clinical Trial Design & Clinical Research Roles and Responsibilities
- 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
Introduction to Start Up and Core Submission Documents
- 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 and Site Level Submission Documents, Adaptation and Translation
- 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
Accordion Panel
- 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
Country Regulatory Bodies, Submission Strategies, Timelines
- Main regulatory bodies and their responsibilities
- Submission strategies and dependencies (main groups on diagrams)
- Submissions and approval timelines
- Comments, conditional approvals, rejections
EudraCT and Upcoming EU Regulations
- EudraCT study registry
- EudraCT GMP database
- EudraCT Annex 1
- EudraCT Annex 2
- EoT notification form
- Upcoming EU regulation
IP Release Document Requirements
- IP release package compilation – responsibilities and timelines
- Documents required for IP release
- FDA requirements vs. EU regulations
- IP release checklist
- FDA filing
Start today
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.
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
Who should attend
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.
Is this academy right for me? We are happy to help you make the right decision.
Email us at info@getcognitio.com and we will contact you.
Course fees
The fee includes:
- Registration fee
- All online-training course material, 100% online available in our learning management system
- Module check points (mini-exams during the training to test your knowledge)
- End-term exam
- Get Cognitio and GCP certificates upon successful completion of the end-term exam
plus exclusive Get Cognitio benefits:
- Get automatically accepted as Ambassadors and earn cash
- 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
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