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Description
A foundational course for individuals considering a career as a clinical research associate (CRA). The course provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, contract research organizations (CROs), clinical research coordinators (CRCs), and principal investigators.
Audience
Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Research Administrators, Sponsors, Students
Meet the Authors
Natasha Williams, BSc – Narra Consulting LLC
- Natasha is a Global Clinical Study Manager with 15 years of industry experience across various roles at the site and CRO levels. She excels in overseeing clinical studies, ensuring compliance with regulations, managing budgets, and fostering strong relationships with stakeholders. She enjoys mentoring and training her fellow colleagues.
Jessica Rosenbluth, MS – Syneos Health
- Working in clinical research for over 14 years, Jessica has spent the majority of her career in the oncology space and has held many leadership positions. She works as a Clinical Trial Manager and received her degrees from Dickinson College and Drexel School of Medicine.
Robert Michalik, JD, RAC – RegulatoryPro Consulting
- Robert Michalik is an FDA regulatory attorney and founder of RegulatoryPro Consulting, which serves biopharmaceutical and medical device clients. He has law and biochemistry degrees and has worked for over 30 years in the biopharmaceutical and medical device industries. He counsels clients in technical, quality, and regulatory areas related to new product development and commercialization activities.
Chinonso Singleton, MS – LIBRE, LLC
- Chinonso Singleton is a clinical research professional with 10+ years of experience. She has managed numerous clinical trials and is passionate about innovative, evidence-based research. Chinonso is dedicated to advancing research and shares insights through training, presentations, and mentorship. She is a Senior Clinical Operations Manager and Tulane alumna.
Clareece West, BSc – West-Fenn Enterprise, LLC
- Clareece has more than 20 years of executive leadership, with expertise in healthcare technology, contract research organizations (CROs), Private Equity, mergers and acquisitions, profit and loss responsibilities, and corporate restructuring. She has worked in global leadership positions at two Fortune 500, Top 20 organizations and two top five CROs, successfully working cross-functionally while building large sales teams and exceeding corporate goals.