Clinical Compliance 2011 - Responsibilities of a Clinical Research Coordinator managing clinical trial

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 preparing a coordinator with how to successfully select a trial, what to do after you select trails, once trials are selected how to get prepared before the trial start, how to successfully submit to the IRB, maintaining the trial master file, CRFs, post trials activities and much more. All these are done with the primary goal in mind; Rights, safety and well-being of patients prevail over science. Also accurate documentation is a key role of a CRC. CRC will learn on how to accurately report, document, handle, store, protect, interpret and verify data.

A CRC plays a key role and is a part of an integral team. Learn about how to work with the 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).
FDA and IRB.
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.
How to select a trial-Activities that are common to most trials.
Linking responsibility to these activities.
Institutional Review Board/ Informed consent
Trial Master File.

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