Clinical Trials Contract Specialist

Training and more

The VIARES Clinical Trials Contract 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 Site Contract Specialist or to broaden your current skills for roles like Clinical Trials Coordinator, Start-Up Specialist and Clinical Research Associates 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 Clinical Trials Contract Specialist program consists of seven consecutive 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.

  • Why clinical trial agreement is needed
  • What is a clinical trial agreement / elements
  • Types of agreeements and when they apply
  • Contracting scenarios / contracting parties
  • Signatures
  • Clinical trial agreement templates
  • Structure of a template
  • Sponsor vs CRO role within a contract
  • Types of investigational sites
  • Common negotiation hurdles
  • How to prepare a site specific agreement
  • Required references to laws and regulations
  • Clinical & regulatory issues
  • Obligations and study conduct
  • Which Sponsor obligations can be applied by a CRO?
  • Effective date and duration of clinical trial agreements
  • Termination options
  • Options for sites to publish results
  • Intellectual property obligations
  • Concept of legal indemnity
  • Liability
  • Insurance obligations
  • Differences with clinical trial insurance
  • Confidentiality
  • What is anti-bribery, what is anti-kickback, differences
  • Why independent contractor status is important?
  • Who and when can assign a clinical trial agreement?
  • Duties and acknowledgement regarding audit
  • Are inspection duties different?
  • Data protection & privacy (GDPR)
  • Concept of legal, operational and financial issues in a contract
    • What is paid, who is paid, how is it paid?
  • Definition of a payee. Who can be a payee?
  • How important is overhead?
  • Taxes
  • Currencies in clinical trial agreements
  • Types of payments
  • Equipment issues
  • Best practices in negotiations
  • Adversarial nature of relationships with site negotiators
  • Quality control, checklist
  • Role of a negotiator in a CRO
    • Sponsor expectations

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 07, 2020

first come – first serve

Program LIVE WEBINARS

DAY

TIME

Kick-Off Webinar &

Access to Program opens

December 09, 2020

START: 5:30 pm CET

END: 6:30 pm CET

BLOCK 1

Introduction to contracts Types of agreements

Clinical Trial Agreement templates

December 19, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 2

Contractual concepts I – operational / regulatory

Contractual concepts II – legal

Contractual concepts III – miscellaneous

January 16, 2021

START: 3:00 pm CET

END: 6:00 pm CET 

BLOCK 3

Clinical trial agreement budget / Site payments

Contract best practices and behaviors

January 30, 2021

START: 3:00 pm CET

END: 5:00 pm CET  

Exam Opens

January 31, 2020

 

Information can be subject to change without notice.

Enrollment

until December 04, 2020

first come – first serve

Program LIVE WEBINARS

DAY

TIME

Kick-Off Webinar &

Access to Program opens

September 08, 2020

START: 5:30 pm CET

END: 6:30 pm CET

BLOCK 1

Introduction to contracts Types of agreements

Clinical Trial Agreement templates

September 12, 2020

START: 3:00 pm CET

END: 5:00 pm CET 

BLOCK 2

Contractual concepts I – operational / regulatory

Contractual concepts II – legal

Contractual concepts III – miscellaneous

September 26, 2020

START: 3:00 pm CET

END: 6:00 pm CET 

BLOCK 3

Clinical trial agreement budget / Site payments

Contract best practices and behaviors

October 10, 2020

START: 3:00 pm CET

END: 5:00 pm CET  

Exam Opens

October 12, 2020

 

Information can be subject to change without notice.

Expert instructor

Bartek Jarosz

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. Working in a regulated environment, or having legal or contract negotiation experience is recommended. 

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:

  • Site Contract Specialist and similar 

You can also take this program to broaden your current skills working in clinical research. 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.

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.

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