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CRA Training for Entry Level

Training presentation

A Clinical Research Associate (CRA) is the person responsible for ensuring that the clinical trial is conducted following Good Clinical Practice (GCP) protocol and applicable legislation.

The Clinical Research Associate (CRA) Training Program will increase your knowledge and skills required for working and keeping up with the latest developments in the clinical research arena as a fully qualified CRA.

The Module 1 – CRA Training for Entry Level is dedicated to junior Clinical Research Associates (CRA), Clinical Research Assistants (CTA), young professionals willing to enter in the clinical trials field as monitors, such as physicians, pharmacists, residents, students, biologists, biochemists.


The participants to Module 1 – CRA Training for Entry Level will benefit of 15% discount to Module 2 – CRA Training for Advanced Level.
 

Clinical Research Associate (CRA) Training Program

Module 1 - CRA training for Entry Level

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Scope:        Understanding scope and execution of monitoring following ICH E6 (R2) §5.18

Language:  English

Price:          350 Euro / 1700 Lei (no VAT refund)

Location:    Park Inn by Radisson Blu Hotel, Jupiter Hall, Lunch at Sharkia Restaurant;
                    2-4 Luterana St., District 1, Bucharest

AGENDA - 2 days

DAY 1 - 27th February 2020

 8:30 –   9:30  REGISTRATION

 9:30 – 11:00        GENERAL OVERVIEW OF CLINICAL TRIALS

  • A short history of Good Clinical Practice (GCP) guidelines
  • Drug development and various types of clinical trials
  • The Principles of ICH GCP (International Council for Harmonisation guidelines for Good Clinical Practice )
  • Declaration of Helsinki
  • Running a clinical trial - the steps

11:00 – 11:30 COFFEE BREAK

11:30 – 13:00       RESPONSIBILITIES

  • Investigators' responsibilities
  • Monitoring responsibilities and limits
  • Sponsor's responsibilities

13:00 – 14:00 LUNCH

14:00 – 15:30       ESSENTIAL DOCUMENTS IN CLINICAL TRIALS

  • The significance of various documents in clinical trials
  • The patient file and other source documents in clinical trials (practical approach)
  • Medical history and physical examination
  • Concomitant medical conditions and related medication
  • Non-clinical investigations in clinical trials
  • ALCOAC principles in practice

15:30 – 16:00 COFFEE BREAK

16:00 – 17:30       INFORMED CONSENT

  • The Informed Consent Procedure
  • Legal representative, witness

DAY 2 - 28th February 2020

 8:30 –   9:30  REGISTRATION

9:30 – 11:00         SAFETY REPORTING IN CLINICAL TRIALS

  • Investigators to sponsor
  • Sponsor to authorities
  • The unblinding procedure

11:00 – 11:30 COFFEE BREAK

11:30 – 13:00       AUDITS AND INSPECTIONS

  • Audits and inspections including frequent audit findings
  • FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), sponsor inspections

13:00 – 14:00 LUNCH

14:00 – 15:30       MISCELLANEOUS

  • Data management, statistical analysis
  • Archiving of clinical trials at the site (ISF) and sponsor (TMF)
  • Site contracts and investigators/institutions payment
  • Subcontracted vendors

15:30 – 16:00 COFFEE BREAK

16:00 – 17:00       TEST

  • Test (multiple choices)
     

The Participation Certificates will be available to be downloaded from the participants’ accounts on www.avantyo.com.

Download here the info brochure of the training.

Discounts are offered for companies sending over 3 participants.
For more information please contact us at info@avantyo.com, 0726 840 456.

Come back soon for more information about the Module 2 - CRA Training Advanced Level!


If you would like to be placed on a waiting list for the next course or you need something else, please let us know at info@avantyo.com. Don’t forget to mention your specific education needs in clinical trials.

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Speakers

Dr. Catalina SARBU Head of the CRO Association in Romania (ACCSCR)
Director Clinical Operations Parexel International Romania
  • General Manager Business Administration & Director Clinical Operations at Parexel
  • 2004-GMBA and Director Clinical Operations–PAREXEL International Romania S.R.L.
  • 2000–Director of the Romanian Representative office of PAREXEL Nederland BV
  • General Practitioner –Center of Hematology, Ploiesti, Romania
  • Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
  • University of Medicine and Pharmacy, Bucharest, Romania -Medical Doctor Degree
Read more

Testimonials

Dr. Cristina Florescu Moraid
Testimonial 2
Gianina Buzuleac - Manager of Clinical Trials Center, Antibiotice S.A.

Avantyo is already a well-known knowledge provider in the field of clinical studies. All the events organized by Avantyo that I attended with my colleagues, have confirmed every time the professionalism of the whole team. The course "CRA - Training for Entry Level" from 27 to 28 February 2020, wanted nothing more than to point out the basic principles and especially the way of thinking in the spirit of GCP (Good Clinical Practice). From my point of view this desire was successfully achieved. We need to develop successful clinical trial projects in Romania and this cannot be possible without thorough knowledge.

We will definitely be present at future events! Good luck Avantyo!

Testimonial 3
Silviya Guncheva

It was a great pleasure for me to take part in the Entry Level CRA Training. The organization of every detail throughout the 2 days of training has been brilliant. We have had the privilege to receive extensive training from Dr Catalina Sarbu, GMBA & Director Clinical Operations in Parexel. Dr Sarbu has managed to summarize well and provide us with the essentials of the various phases of the clinical trial process. Her presentation was interactive and therefore she has managed successfully to draw the attention of the audience throughout the whole time. Each part of the training has contained salient examples from Dr Sarbu’s practice. I was able to receive a great deal of knowledge which will allow me to progress further to the next step of my career in clinical practice.

Testimonial 4
Alexe Lavinia Claudia

My name is Alexe Lavinia Claudia and I am a doctoral student at the University of Medicine and Pharmacy Craiova. I attended this course without expectations but knowing that we will receive a certificate when accomplishing it. Why do I say that I had no expectation? Because having them, we forget to enjoy the act itself. What did I find here? A wonderful lady, Catalina Sarbu, who for two days calmly explained to us, exemplified us, so that in the end we get the appropriate level of beginner monitors. Thank you! And see you at the next course!

Testimonial 5
Testimonials from Evaluation Forms

“Congratulations on choosing the speaker; her input & performance was brilliant. Location was central, very clean, lunch very tasty & the staff very professional. Congratulation to Avantyo! Good work! Good luck with the next ones!”


“This course is an excellent initiative. The maximum grade!  Thank you!”


“The course was very constructive. The speaker performed a very good presentation”


“Congratulations to Dr Catalina Sarbu!”


“Excellent training, very comprehensive and perfect organized!”

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