Jim Kremidas, Executive Director, ACRP

ACRP Publishes Functional Competency Guidelines for Principal and Sub Investigators

The Association of Clinical Research Professionals (ACRP) has published a comprehensive set of core competency guidelines for Principal Investigators (PIs) and Sub Investigators. Functional Competency Guidelines for Principal and Sub Investigators is an important contribution to ACRP’s growing set of resources aimed at translating the Joint Task Force for Clinical Trial Competency guidelines […]

Michael D. Watkins, Cofounder, Genesis Advisors

Why Do Some New Leaders Stumble Out of the Starting Gate?

While many clinical trial professionals struggle with the lack of clear career paths in the industry, there are tools, tactics, and best practices to help spot and leverage new opportunities. In this occasional series, we’ll hear from leading experts both in and outside the clinical trial industry as they offer insights on how to […]

BIMO Inspections: Recommendations for Sponsors

Clinical Researcher—June 2019 (Volume 33, Issue 6) PEER REVIEWED Mary Kay Kessinger Sobcinski, RN, BSN, MHA; Susan Wiskow, CCRP   The U.S. Food and Drug Administration’s (FDA’s) Bioresearch Monitoring (BIMO) program is designed to protect the rights, safety, and welfare of subjects, verify the accuracy and reliability of clinical study data, and assess study compliance […]