Marian Fisher

Transitioning from CRC to CRA: Is the Time Right for You?

It’s a common question in the clinical research enterprise, but one that comes with no easy answer: How do I make the leap from being a clinical research coordinator (CRC) to being a clinical research associate (CRA)? ACRP 2018 speakers Marian Fisher, RN, CCRC, a senior CRA, and Thomas Boothby, a CRA II, both with […]

David Burrow

FDA’s Burrow Offers Insider Inspection Tips

“Quality is a journey, not a destination.” That’s the message imparted by the U.S. Food and Drug Administration's (FDA's) David Burrow during his ACRP 2018 meeting session on “CDER BIMO: Compliance and Enforcement: What You Need to Know.” Burrow, PharmD, JD, is director of the Office of Scientific Investigations at the Center for Drug Evaluation […]

Chavon Steele

The Lead Monitor Role Steps into the Spotlight

In many organizations, the term “lead monitor” is applied to a leadership role in clinical development and not to an actual position, but that is beginning to change, speakers at ACRP 2018 said today (April 30). In their presentation on “The Role of the Lead Monitor and How to Become an Effective One,” Chavon Steele, […]

Shirley Trainor-Thomas, MHSA, Chief Strategy Officer, eNRE

Clinical Trial Professionals Should Wear Their ‘Halo’ Proudly

You’re a healthcare angel and your clinical trial work has a “halo effect” on your entire organization. It’s not bragging. It’s a fact. Your next assignment: Make sure others – especially top brass – know it, too. “What you do benefits your organization in so many ways,” Shirley Trainor-Thomas, chief strategy officer at eNRE, told […]

Research Professionals Experience Trials from the Other Side

If you were to look at the spectrum of roles Peter and Vicky DiBiaso have played in the drug development enterprise, you could be forgiven for thinking their professional lives have been naturally leading up to their current levels of personal involvement in clinical research as trial volunteers and advocates. It certainly feels that way […]