Study Start Up Specialist

Training and more

The VIARES Study Start Up Specialist program is more than just training.

We aim to improve employability as Clinical Research Professionals for our participants. Our setup enables participants to complete their program next to a full-time job or in a focused effort. On successful completion of this program graduates will have acquired knowledge, skills and competencies to start at an entry level role as Study Start Up Specialist and others.

Enjoy all our services during your program enrollment. 

  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • VIARES ACADEMY certificate
  • GCP certification
  • modules including
    • e-learnings
    • assignments
    • knowledge checks
  • VIARES ACADEMY certificate
  • GCP certification
  • Talent Profile to connect you with open jobs
  • Talent Days to connect with our industry partners and learn about career opportunities
  • Talent Portal to apply for posted jobs available to the Talent Program Community

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
  • join the live instructor-led webinars
  • take the final exam

Successfully complete all activities to obtain your VIARES ACADEMY 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
  • Additional submissions and approvals
  • Import / Export licenses
  • SSU maintenance: ongoing submissions and amendments
  • Amendment submission strategies
  • Amendment approval timeliness
  • End of Trial and Clinical Study Report
  • IP release package compilation – responsibilities and timelines
  • Documents required for IP release
  • FDA requirements vs. EU regulations
  • IP release checklist
  • FDA filing

Expert instructor

Bartek Jarosz

Program Dates​

We recommend to join the kick-off webinar, where we provide guidance and tips on how to best take the program.

Enrollment

until September 01, 2020

first come – first serve

Program LIVE WEBINARS

DAY

TIME

Kick-Off Webinar &

Access to Program opens

September 02, 2020

START: 5:30 pm CET

END: 6:30 pm CET

BLOCK 1

Introduction to Start Up and core submission documents

Country and site level submission documents, adaptation and translation

September 05, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 2

VHP submission process vs. „regular” country process

Country regulatory bodies, submission strategies, timelines

September 19, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 3

Additional submissions, Start Up maintenance and Study End

IP release document requirements

October 03, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

Exam Opens

October 05, 2020

 

Information can be subject to change without notice.

Enrollment

until June 29, 2020

first come – first serve

Program LIVE WEBINARS

DAY

TIME

Kick-Off Webinar

June 30, 2020

START: 5:30 pm CET

END: 6:30 pm CET

BLOCK 1

Introduction to Start Up and core submission documents

Country and site level submission documents, adaptation and translation

July 04, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 2

VHP submission process vs. „regular” country process

Country regulatory bodies, submission strategies, timelines

July 18, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 3

Additional submissions, Start Up maintenance and Study End

IP release document requirements

August 01, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

We are using Microsoft Teams for the webinar. Information can be subject to change without notice.

Enrollment

opens July 01, 2020

first come – first serve

Program LIVE WEBINARS

DAY

TIME

Kick-Off Webinar

August 05, 2020

START: 5:30 pm CET

END: 6:30 pm CET

BLOCK 1

Introduction to Start Up and core submission documents

Country and site level submission documents, adaptation and translation

August 08, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 2

VHP submission process vs. „regular” country process

Country regulatory bodies, submission strategies, timelines

August 22, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 3

Additional submissions, Start Up maintenance and Study End

IP release document requirements

September 05, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

We are using Microsoft Teams for the webinar. Information can be subject to change without notice.

 

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 academy@theviares.com and we will contact you.

Typical jobs with this skills

You could apply for jobs like:

  • Study Start Up Specialist or similar 

It is also a great role for those who want to join the industry but do not fancy travelling associated with a CRA job, you will have the same options for superb career growth, just through a different pathway. You can also take this program to broaden your current skills working in clinical research, i.e. in a role of a Clinical Trials Assistant or CRA.

Affordable and flexible

Our Programs come at very affordable cost wherever you are in your career.

Nonmember: EUR 299 net | Member: EUR 199 net

Invite your friends with your personal discount code to sign up and get refunded.

Our Programs come at very affordable cost wherever you are in your career.

Study Start Up Specialist

You’re only 1 click away from changing your life. What are you waiting for? SIGN UP TODAY!