Are you a new Clinical Research Coordinator? Tips on how to get started, what to expect
This clinical research webinar will discuss the role and responsibilities of an efficient well rounded Clinical Research coordinator and what to do pre and post trial period to comply with GCP and other regulations.
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.
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).
- 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.
- Education and Outlook.
- 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 all personnel in:
- Healthcare providers interested in exploring the field of Clinical Research
- New Clinical Research Coordinators (1-2 years)
- New Principal Investigators
- Administrative managers in charge of Clinical Research
- Regulatory Compliance Associates and Managers
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 7 years. She has experience with conducting clinical trials, investigator initiated trials, starting a research program in a hospital, health services research, grant submission, business development and fundraising. She served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.