Clinical Trials Administrator Archives – July 1, 2003
July 1, 2003
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The devil is in the details when it comes to research coordinators
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. -
Finders keepers: How to retain good research staff
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. -
Spend a dollar on training, save a few more on fines
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. -
Anchor your training program with Ethics 101
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. -
Do they really understand your authorization form?
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. -
Informed consent goes beyond a signed form
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.