Guest Blogger Angela Roberts, Head of CRA Recruitment, CRAresources

Are You Reading Fraudulent Resumes?

Don’t you love it when a terrific clinical research associate (CRA) just falls out of the sky? That is what happened to me recently—an outstanding resume seemed to literally drop in my lap. This CRA had the perfect education, terrific experience with a reputable contract research organization, and a wonderfully diverse therapeutic listing. Was she […]

Mutual Respect Key to Successful Informed Consent Program

Informed consent is not just about documentation, says Erica Jonlin, a regulatory manager at the University of Washington. Done properly, it can improve the pool of patients and the overall reputation of clinical trials, she adds. It’s incumbent upon the person doing the informing to understand the study backward and forwards—that means without having to […]

Jim Kremidas, ACRP Executive Director

FDA Proposal Gives Patients Easier Way to Give Input on New Medical Products

Patients would have an easier way to communicate their views on new medical products to the FDA under a recent proposal. The Food and Drug Administration is considering establishing an Office of Patient Affairs to support and coordinate patient engagement activities across the agency's medical product centers for drugs, medical devices, and biologics, according to […]

Former FDA Commissioner Robert M. Califf, MD

Former FDA Commissioner Calls for Increased Clinical Trial Education

Even as the clinical research enterprise is poised for “transformational progress,” swifter advancements in clinical trials are hampered by wariness over technology, miscommunication between industry and regulators, and a lack of education, former U.S. Food and Drug Administration (FDA) Commissioner Robert M. Califf, MD, said during a Clinical Trials Transformation Initiative (CTTI) webinar on March […]

Clinical Trial Operations (GCPs)

Core Competencies Could Strengthen Clinical Workforce

Having a set of core competencies will be “incredibly helpful” in addressing the current clinical research associate (CRA) shortage, says Bonnie Miller, RN, MS, a clinical research consultant and president of the Association of Clinical Research Professionals (ACRP) Northern California Chapter. “This job requires tangible standardized role competencies,” says Miller, who is also an adjunct […]