Upcoming Clinical Trials Monitor (Clinical Research Associates) Course

 

UNIVERSITY OF NAIROBI KAVI-INSTITUTE OF CLINICAL RESEARCH AND CLINWIN RESEARCH SERVICES (CRO) ARE OFFERING A SIX (6) DAY COURSE ON CLINICAL TRIALS MONITORING

Venue/Country: KAVI-ICR, University of Nairobi, Kenya

Dates:  To be communicated soon

Introduction:
Clinical Research Associate (CRA); also, commonly known as a monitor supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor.
The sponsor, whose intent is the research of pharmaceuticals, biologics, or devices, may employ these individuals either directly or indirectly via contract research organizations (CROs), or as independent consultants or contractors.
There is current global need for more quality, efficient and cost effective clinical trials to provide evidence for the safety and effectiveness of life saving medical technologies.
The industry demand for the qualified Clinical Research Associates (CRA) is growing year by year and this expected to continue in the future.
The training will cover the International Harmonization Good Clinical Practice (ICH GCP), Federal Drug Administration (FDA), European Medicines Agency and local health authorities clinical trials regulations.

Who should attend?
The course is designed for individuals with at least two years’ work experience in clinical research work at Investigator site level, Sponsor (academic, Pharmaceutical or not for profit research organizations) or related health care industry.

These include individuals performing the role of:
Study Coordinators
Research Nurses
Internal Quality Assurance personnel
Internal trials Monitors
Clinicians/Physicians
Pharmacists
Laboratory Scientists
Public Health Professionals
Bio-Ethics and Regulatory members

At the end of this course the participants should be able to know:

  • Introduction to Clinical Research
  • Trial Master File and Essential Documents
  • Adverse Events and Safety Monitoring and pharmacovigilance
  • Patient Recruitment and Retention
  • The principles and phases of drug development
  • Investigational Product Management
  • Clinical trials monitoring (Investigator site selection, study start up, site initiation, interim monitoring and close out; and Risk based monitoring approach)
  • The concepts and principles of clinical trials management
  • Regulations in clinical trials
  • Clinical trials contracts and budgets preparation, negotiation
  • Clinical trial project management
  • Data Management and Technology¬†

Training Methods:
Teaching will be in the form of lectures, case studies, debates and visits to clinical research facilities. KAVI-ICR will provide training materials to participants.

This will comprise of 5 days theoretical training; class practical and trial site visit and one day Multiple choice questions and practical exam.

How to Register;
Send us an email and brief CV to: training-coordinator@kaviuon.org and copy info@clinwinresearch.com

Other Details;

Course payment instructions will be given soon after registration
Subsistence allowance and accommodation to be arranged & paid for by the Participants.

The course fee includes daily lunch and tea/coffee.

 

Cost
Ksh 100000 or USD 1000

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