Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team

Instructor: Madhavi Diwanji
Product ID: 702146
  • Duration: 60 Min

recorded version

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Read Frequently Asked Questions

This training on a compliant clinical research team will focus on how Clinical Research Coordinators should work in a research team to ensure success of the clinical trial at your site.

Course "Fundamentals of Clinical Research - Key players and roles for a successful and compliant research team" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

With the growth of the Biotechnology industry, Clinical Research Coordinator (CRC) positions are expected to increase by 2016. The CRC is the heart and soul of the trial thus it is important to be well organized and well informed about the role and responsibilities.

This presentation will help with you learn all the aspects of a clinical trial i.e.; how to successfully select a trial, IRB, maintaining the trial master file, CRFs, post trials activities and much more. Also accurate documentation is a key part of any research team. You will learn on how to accurately report, document, handle, store, protect, interpret and verify data.

The presenter will provide practical tips on how to work with the research team of other professionals to help with a successful outcome while maintaining integrity of the trial. This session will include the key principles of GCP as defined by the ICH as well as incorporate FDA regulatory inspection strategy to identify areas of common deficiency.

Areas Covered in the Seminar:

  • ICH guidelines and Good Clinical Practice (GCP).
  • Types and Phases of Clinical Trials.
  • Role and responsibilities of a Clinical Research coordinator.
  • Key aspects of the role and key players involved in a trial.
  • Role of the Principal Investigator.
  • Activities that are common to most trials.
  • Linking responsibility to these activities.
  • Institutional Review Board/ Informed consent.
  • Trial- from selection to closing.

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel

  • Healthcare providers interested in exploring the field of Clinical Research
  • Clinical Research Coordinators
  • New Principal Investigators
  • Administrative managers in charge of Clinical Research
  • Regulatory Compliance Associates and Managers

Instructor Profile:

Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor. She has worked in the healthcare industry in various roles for the past 20 years. She has worked in healthcare research with a primary focus on cardiology for 8 years. She has experience with monitoring and conducting clinical trials, investigator initiated trials, starting a research program in a hospital, health services research, clinical trial monitoring, working with various Principal Investigators, IRB applications, grant submission, business development and fundraising. She has served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.

Topic Background:

Clinical Research coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the supervision of the Principal Investigator (PI). Although PI is responsible for the conduct of the trial, it has been said that the CRC is the heart and soul of a trial and that ultimately it’s the CRC who carries forward the research goals, thereby playing a significant role in the success of the research study. Many people are part of a research team and everyone has their own role: PI, Co-I, Pharmacist, Regulatory personnel, Research coordinator, Research Nurse and other technical personnel.

All the activities of a CRC are done with the primary goal in mind - Rights, safety and well-being of patients prevail over science.

Well controlled and well conducted clinical trials are important to both sponsors and investigator sites. Compliance with Good Clinical Practice and ICH guidelines will ensure quality data, speeds up the review process for new drugs and decreases the costs to sponsors. Safeguarding trial subjects is a key priority. Compliance will also ensure successful FDA inspections.

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