Insights

Society must fulfill its obligations to the nursing profession by ensuring clinical research nurses receive the training and mental health support necessary to be successful in their role. In turn, they can fulfill their obligations to society by providing quality care.

“Trial by fire.” “Test of mettle.” “Proving ground.” These are among the common phrases that describe the collective origin story of many clinical researchers and their not-so-gentle assimilation to this industry. Most stories have a similar inception; however, each storyline is unique as it unfolds in its own incredible fashion.

In the fast-paced and highly regulated world of clinical research and pharmaceuticals, project managers play a pivotal role. Among the many skills at which these professionals need to excel, assertiveness stands out as a critical trait that can significantly influence the success of clinical projects.

This column shares feedback received recently on careers in the medical device research field and the state of the sector from Stacey Banks, MS, MBA, CCRC, ACRP-MDP, Director of the Clinical Research Support Office for Inova Health System in Virginia, and Danyel Carr, MS, CCRA, Senior Director of Clinical Affairs for Argon Medical in Texas.

Although the U.S. Food and Drug Administration’s oversight of medical devices first came under the Food, Drug, and Cosmetic Act in 1938, the regulation of medical devices started in 1976. The pathways for medical devices and drugs to reach the market are quite different, as summarized in this article.