CLINICAL RESEARCH ASSOCIATE TRAINING

Brenes Isabelle - Douxfils Jonathan - Van Orshoven Karolien (15 h - 2 ECTS)

Douxfils Jonathan – After being graduated in pharmaceutical sciences in 2011, Dr. Jonathan Douxfils obtained his PhD in biomedical and pharmaceutical sciences in 2015. In 2018, he gained an academic position at the University. The researches directed by Dr. Douxfils play a leading role in the establishment of guidelines for the laboratory measurement of DOACs in the routine setting. These recommendations have been used so far by several Expert Societies involved in the field of thrombosis and hemostasis. He also exercises his expertise as a pharmacovigilance expert at the European Medicine Agency, is co-chairmen of the SSC Control of Anticoagulation at the International Society of Thrombosis and Haemostasis (ISTH) and is also the co-founder and the CEO of QUALIblood, a Contract Research Organization (CRO) aiming to provide the industries, hospitals and universities with all the analytical services for blood investigations and hemocompatibility testing.

Passionate about clinical and laboratory research, he is involved in several projects aiming to solve pharmacological and/or epidemiological problems especially in thrombosis and hemostasis. Thanks to his translational view, i.e. from basic research to post-marketing pharmacovigilance, of the pharmaceutical and biomedical market, his collaborations with key opinion leaders but also with field practitioners, Dr. Jonathan Douxfils puts its expertise and know-how at the services of projects aiming to improve the safety and effectiveness of therapeutic agents in order to promote public health.

Brenes Isabelle – Isabelle Brenes is currently Project Manager at Bristol-Myers Squibb via Syneos Health and a visiting lecturer at UNamur. After obtaining a Master in Chemistry, she started her career working as an academic researcher in the field of inflammatory disease. Following this experience, she moved to the clinical research industry and has endorsed various roles within clinical operations in Belgium. Working on a broad diversity of therapeutic domains, for various sponsors and CROs, she has more than 12 years of experience in managing trials and supporting clinical sites and pharmaceutical companies to conduct clinical studies in compliance with Good Clinical Practice and local regulation. On top of her clinical trial expertise, Isabelle is also very interested in developing new Business opportunities and has recently obtained a Master in Executive Management at Solvay Brussels School.

 

Theory: 15 h

Title Clinical Research Associate Training (2 ECTS)
Program

 

•  Clinical trial study team

•  Quality of clinical patient data

•  Problem solving and management of issues: deviations, root cause analysis, corrective and preventive actions

•  Essential documents in clinical trials

•  Quality of laboratory data in a clinical trial

•  Clinical trial navigation in a site (logistic)

•  In a patient file: data interpretation, data flow

•  Closing remarks

Sources Written notes.
Objectives and expected results As a Clinical Research Associate (CRA), it is important during all site visits you are self-confident, knowledgeable and a trustworthy partner for all stakeholders throughout all stages of a trial. A CRA is involved in all stages of a clinical trial, including identifying and setting up an investigational site, monitoring of the trial and then closing it down. The CRA will also act as the main line of communication between Sponsor and Investigator and is the primary contact for the site. In this course, you will gain insight into basic monitoring tasks, how to communicate and present a trial to site staff and act with confidence in your CRA position.
Prerequisites Statistics and Clinical Trials Course.
Teaching methods Notes are provided in English.

Discussions on clinical cases and real situations coming from hospital and pharmaceutical companies will be proposed.

Exercises and/or examples will be provided at each session (3 hours of theory and 2 hours of exercises).

Exam modality The written exam is based on practical cases.

TITLE

Clinical Research Associate Training (2 ECTS)

 

PROGRAM

  • Clinical trial study team
  • Quality of clinical patient data
  • Problem solving and management of issues: deviations, root cause analysis, corrective and preventive actions
  • Essential documents in clinical trials
  • Quality of laboratory data in a clinical trial
  • Clinical trial navigation in a site (logistic)
  • In a patient file: data interpretation, data flow
  • Closing remarks

SOURCES

Written notes.

OBJECTIVES AND EXPECTED RESULTS

As a Clinical Research Associate (CRA), it is important during all site visits you are self-confident, knowledgeable and a trustworthy partner for all stakeholders throughout all stages of a trial. A CRA is involved in all stages of a clinical trial, including identifying and setting up an investigational site, monitoring of the trial and then closing it down. The CRA will also act as the main line of communication between Sponsor and Investigator and is the primary contact for the site. In this course, you will gain insight into basic monitoring tasks, how to communicate and present a trial to site staff and act with confidence in your CRA position.

PREREQUISITES

Statistics and Clinical Trials Course.

TEACHING METHODS

Notes are provided in English.

Discussions on clinical cases and real situations coming from hospital and pharmaceutical companies will be proposed.

Exercises and/or examples will be provided at each session (3 hours of theory and 2 hours of exercises).

EXAM MODALITY

The written exam is based on practical cases.

Last modified: Dicember 17, 2019