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Online Program>>Clinical Project Management                                                                                 
One Day Online Training in Clinical Project Management
(Attend LIVE or Access Recording)
​
​Clinical trials are highly regulated multi-dimensional projects that require constant interactions between the regulators and the sponsors, investigators, other personnel, and even patients involved in the conduct of a given trial. There are many diverse tasks involved in the conduct of a clinical trial starting from the development of a clinical trial protocol, finding and starting clinical trial sites, filing of an IND or IDE application, approvals from IRBs, numerous documents need to be collected to demonstrate compliance with regulations; managing supplies, collecting data, writing reports, and many other things. Clinical project managers need to understand, implement, and trouble-shoot practically all aspects of the clinical trial under them. Clinical project managers have to build teams and have clear perspective of what may be needed for assuring compliance with FDA requirements of a given clinical trial at all times. This one-of-a-kind program will train you in regulatory affairs, clinical operations, monitoring, patient recruitment and retention, planning, medical writing, safety monitoring and practically all major aspects of running a clinical trial.
Why should you attend:
​

​If you are looking to work in the clinical trial industry as a clinical research associate, a clinical project manager, a regulatory affairs expert, an investigator, a coordinator, a nurse, an ethicist, or any of the myriad roles needed to run a clinical trial, this boot-camp is for you. This is the only course of its kind that covers practically all aspects of conducting a clinical trial from a sponsor, physician investigator, regulators and CRO perspective. Students will be required to work as a team and apply the techniques learned in the classes for developing their respective project plans. This one day training is run by experts working in the clinical trial industry to provide a first-hand overview of the practical aspects of conducting a clinical trial. Practical tips for management of a clinical trial project will be provided using case studies from the presenter’s personal experience. If you are aspiring to be a clinical project manager, are sponsoring a clinical trial, supervise clinical trial operations, or would like to become a clinical site, this training is a must for you.
Areas Covered in the Session:
  • Good Clinical Practices (GCP)
  • Setting up the Clinical Trial Team and Clinical Site
  • Clinical Trial Documentation Practices
  • Introduction to Project Management for Clinical Trial Professionals
  • Tools for Project Managers 
  • Monitoring of Clinical Trials
  • Practical Issues with Clinical Project Management 
Date: May 25, 2023
Time: 10 AM - 5 PM EST
Register Online

Speaker
Mukesh Kumar, PhD, RAC (Regulatory Affairs and Quality Assurance), Brij Strategic Consultations, USA

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com

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