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The audit team from Johnson & Johnson (J&J) Pharmaceutical Research and Development in San Diego has never hired a clinical research coordinator (CRC), but that doesnt mean it doesnt have some very strong opinions about the skills a good one should have.
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Carolinas Research Associates in Charlotte, NC, is a small company: there is a total of eight staff members, four of whom are research coordinators. Over the seven years the company has been in business, CEO Yvonne McCracken, MPH, and co-founder Sara Brandon have discovered a few truths about out how to find and keep good employees.
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When selecting educational topics for your clinical research staff and investigational review board (IRB) members, where do you start? Begin with the ethics of clinical research, advises Lynette M. Schenkel, administrative director of research and academic affairs at Beth Israel Deaconess Medical Center in Boston.
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At first glance, developing a template for an informed consent form seems like a simple thing. But ensuring consent forms accomplish those elements has proven tricky for researchers time and again, sometimes at a high price to studies and participants.
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Do you want a compliant clinical research program? Start with training and education, clinical research administrators advise. Otherwise, you could end up paying millions if your staff make a critical mistake, such as improper billing.
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In cities all over the country, Health Insurance Portability and Accountability Act (HIPAA) privacy notices are being shoved into the hands of patients. These notices, presumably explain clearly what HIPAA is and the rights that John and Jane Q. Public now have. Yet, one readability expert found that privacy notices are written at levels most likely to go right over the general publics head.
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SARS requires constant readiness, at least until health authorities determine that the virus is no longer spreading, says Susan Kinter, RN, JD, director of claims litigation and risk management at the University of Maryland Medical System in Baltimore.
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Health care risk managers should exercise caution when implementing SARS-related work restrictions and other responses to the deadly virus, says Kent Jonas, JD, a labor and employment attorney with the firm of Thelen, Reid & Priest in San Francisco. Acting hastily might result in a lawsuit or charges of federal labor violations, he warns.
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A Hayward, CA, jury recently returned a $14.85 million verdict against John Carper, MD, an Alameda family practitioner, and Alameda (CA) Hospital for delay in performing a cesarean, resulting in brain damage and cerebral palsy.
