The leaders of institutions involved in the conduct of clinical research have the option of various models for managing their clinical research personnel. When considering a centralized or hybrid model for management of such professionals, experts advise that the organizational leaders must engage stakeholders early and often in the process, and build in flexibility to acknowledge there is never a one-size-fits-all approach.
According to Mindy Muenich and Nirmala Thevathasan from Huron Consulting Group, external economic and regulatory pressures continue to create challenges in the field of clinical research, including:
- Changes to the research funding landscape
- Increasing regulatory and reporting requirements
Elements of the internal dynamics of a research enterprise such as calls to centralize administrative service operations for research and to improve workflow, time to enrollment, and cost recovery are all challenging institutions to think strategically about how to manage their clinical research personnel and operations in an efficient and cost-effective manner.
Muenich, a director with Huron Consulting Group’s research services practice area who previously served as the director of Clinical and Translational Research Office at the Cincinnati Children’s Hospital Medical Center and UC Health, has first-hand experience with these challenges.
While flexibility is the key when considering a centralized approach, Thevathasan stressed a few bedrock ideas. “Regardless of your staffing model, standardized processes are critical to successfully conducting research,” she says. Thevathasan is a manager with Huron Consulting Group and was previously the associate director of the Clinical Trials Office at The Children’s Hospital of Philadelphia.
Muenich and Thevathasan advocate for institutional leaders taking an in-depth look at the strategic and financial goals for engaging in research, and aligning their staffing models accordingly.