Career Tip: Invest in Your Continued Education

Carla G. Perna, BS, CCRP, recently reflected on her career and lessons learned as she advanced from research assistant to program director, and on the importance of staying on your toes. Q: What advice do you have for clinical research professionals on how to advance their careers? A: Get your degree; get certified! Pick a […]

Are Your SOPs Ready for Prime Time?

Standard operating procedures (SOPs) are the foundation for any effective clinical research program, experts agree. The U.S. Food and Drug Administration (FDA) agrees, too. It’s one of the most common areas the agency scrutinizes during an inspection. Officially, SOPs are defined by the International Conference on Harmonization (ICH) in its Good Clinical Practice Guidelines (ICH […]

Safe Clinical Trials Demand Aggressive Risk Analysis

Assessing risk in advance is the key to running a safe, successful clinical trial, says Peggy Fay, PhD, RN, CCRC, a clinical research consultant with Clinical Research Facilitators in Buford, Ga. The stakes are high. She recently worked on a trial where the sponsor and team did everything right—except consider the possibility the product wouldn't […]

Tiny Regulatory Wrinkles Can Create Big Problems for Clinical Trials

Beware the 234,812-word federal regulation bearing gifts. Even if a new law wasn’t intended to cover clinical research, it can still sneak up and impact the way sites do business, says David Vulcano, LCSW, MBA, CIP, RAC, with HCA (Hospital Corporation of America) in Nashville, Tenn. “Sometimes, the word ‘research’ isn’t even in a federal […]

CRA Job Landscape: Fewer, Tougher Jobs

Today’s clinical research associates (CRAs) have some justification if they feel like superstar college athletes nailing down big signing bonuses. They should enjoy it while they can. The job landscape of the future could be quite a bit different, says Jeff Kasher, president of Patients Can’t Wait LLC. Thanks to risk-based monitoring (RBM) (see the […]