The Lead Monitor Role Steps into the Spotlight

Chavon Steele

Chavon Steele, MBA, CCRA, Medtronic

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, MBA, CCRA, senior clinical trial monitor, and Ashley Costello, CCRA, principal clinical research monitor, both with Medtronic, defined lead monitors as:

  • The expert on all monitoring-related aspects of assigned studies
  • The primary monitoring contact for the relevant study monitors as well as the clinical team
  • The liaison between the study team and the monitoring group

It’s a position that requires a special skillset in terms of project management, leadership, an orientation toward results, and tactfulness (among other soft skills).

Steele and Costello recently surveyed monitors, lead monitors, monitoring managers, and report reviewers in pharmaceutical and medical device firms and in contract research organizations regarding the lead monitor role. They found that effective communication was the most highly valued characteristic the respondents would want in a lead monitor for a study in which they were involved as a monitor themselves.

Among the most highly valued activities or responsibilities the survey respondents said lead monitors conduct were developing monitoring tools (e.g., monitoring plans, report templates, letter templates), mentoring monitors on study teams, and overseeing/managing metrics tied to the studies to which they are assigned.

Further, 95.5% of those surveyed said that “it was extremely or very important for a lead monitor to have the ability to build a strong relationship with the study team,” according to Steele and Costello. In this arena, the lead monitor is key to overseeing general communication, meetings, document development and management, monitoring plan oversight, monitoring visit report management, and metrics and data.

The presenters also outlined the characteristics of a great leader that apply to lead monitors, including strengths at creating a team atmosphere, and discussed how to develop a career path to becoming a lead monitor.

Author: Gary Cramer