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Moving the Role of the CRC and CRA into the 21st Century: Opportunities and Challenges
Session Chair(s)
Terri Hinkley, BSN, MBA, RN
Deputy Executive Director
Association of Clinical Research Professionals (ACRP), United States
The clinical research industry continues to evolve at a rapid rate. Changes and/or clarification in regulatory guidelines are requiring sites to increase their quality control and trial oversight activities, typically by the clinical research coordinator (CRC) and continue to change the traditional role of the study monitor. This session will explore the changes in each role as well as the opportunities to continue the evolution of both roles. Current training needs for each role will be evaluated and the next steps required of all stakeholders will be discussed.
Learning Objective : Describe the industry changes affecting the role of the clinical research coordinator (CRC) and clinical research associate/monitor (CRA) including the impact on the skillsets and abilities required for each role; Evaluate the changes or modifications required to the training and development needs of both roles; Provide insight into the stakeholder support that will be required to change the role specifications of these two critical roles.
Speaker(s)
21st Century Clinical Monitors: How Will the Industry Address Significant Shortages in Experienced, Well-trained Talent?
Lisa C. Feeney, MBA
ExecuPharm, Inc., United States
Vice President, Clinical Operations
Designing the Future of the Role of the Clinical Research Coordinator
Claudia Christy
Consultant, United States
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