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 […]

ACRP Announces Initiative to Promote, Validate Harmonized Competence for Clinical Research Professionals

The Association of Clinical Research Professionals (ACRP) today announces a major initiative to promote and validate competence in clinical research. Starting in 2017, ACRP’s industry-leading certification programs will be harmonized with the core competency framework developed by the Joint Task Force (JTF) for Clinical Trial Competency, whose contributors and collaborators include leading organizations representing clinical […]

Don’t Overlook the Human Factor When Addressing Consent Issues

There’s been lots of talk about how the clinical research enterprise will need to address new informed consent challenges raised in relation to eConsent, genomics, vulnerable populations, and more. Each issue requires new ways of guaranteeing everyone’s eyes are wide open during the conduct of informed consent. Ultimately, however, it’s still the human factor that […]

Accountability in Clinical Research “Two Way Street”

"If we hold our employees accountable, we have to hold ourselves accountable," says industry pathfinder David Morin, MD, RPh, FACP, CPI. As Director of Clinical Research at Holston Medical Group, he's worked hard with his team to come up with a robust accountability program designed to improve overall performance -- not to point fingers. Working […]