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Clinical Research Associate (CRA) - Advanced

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 2, CRA Training – ADVANCED, is dedicated to Clinical Research Associates (CRA), Senior Clinical Research Associates (CRA), Junior Clinical Associates, Clinical Research Assistants (CTA) and other professionals who have already graduated the Entry-Level Module 1 of CRA Training as all other clinical studies specialists (physicians, pharmacists, biologists, biochemists etc.) willing to improve their monitoring skills.

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

CRA Training - Advanced

Module 2 - CRA training Advanced

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

Language: Romanian / English, depending on participants

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

Discounts: 5% for over 3 participants and 10% for over 5 participants from the same institution. For assistance please contact us at anca.bejenaru@avantyo.com, 0726 840 456.

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 - SEPTEMBER 17, 2020

8:30 –  9:30 REGISTRATION

9:30 – 11:00 MONITORING IN CLINICAL RESEARCH

  • Role, tasks and responsibilities of a Clinical Research Associate (CRA)
  • Qualification of monitors – annual re-certification

11:00 – 11:30 COFFEE BREAK

11:30 – 13:00

  • Methods of monitoring and Data Surveillance
  • Electronic Record in Clinical Research (general requirements)

13:00 – 14:00 LUNCH

14:00 – 15:30

  • Understanding Essential Documents and their management
  • Cross-check of documents (Case scenarios)

15:30 – 16:00 COFFEE BREAK

16:00 – 17:30

  • Screening and site-selection activities including QV (evaluating the enrolment potential)
  • Essential points of a successful IV (initiation Visit)


DAY 2 - SEPTEMBER 18, 2020

8:30 – 9:30 REGISTRATION

9:30 – 11:00

  • Fraud in Clinical Research
  • Investigators anti-bribery screening

11:00 – 11:30 COFFEE BREAK

11:30 – 13:00

  • Monitoring and safeguarding compliance with regulatory requirements, to protocol, manuals, systems.
    • Aspects of patients’ recruitment and retention (outlook strategies on the potential site numbers)
    • Safety reporting

13:00 – 14:00 LUNCH

14:00 – 15:30

  • Audit preparation, participation, answers

15:30 – 16:00 COFFEE BREAK

16:00 – 17:00

  • Communication with the site, the colleagues, the sponsor
  • TEST (multiple choices)

Note: due to the interactive nature of the agenda, the timings may change.

***

Certificates of Attendance: after the completion of the course, they will be available to be downloaded from the participants’ accounts on www.avantyo.com.

Attendance only by online reservation. Booking available after registering on this site.

For discounts and assistance please contact us:
info@avantyo.com, anca.bejenaru@avantyo.com, 0726 840 456.

Come back soon for more information about this course!


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

Schedule

Select the date you prefer:

17-18 September 2020 Available seats 25 / 25 TBD
Training price 1700 Lei or 350 Euro for a two days course.
No VAT refund.

Discounts:
• 5% for over 3 participants
• 10% % for over 5 participants

Payment by credit card or bank transfer

BOOK & PAY DEADLINE: 18.05.2020

Please login or register on this site in order to book your seat.

Login / register to book