In February, Dr. Suzanne Rose from Stamford Health presented the webinar “Developing Leaders and Building Successful Careers in Your Organization.” She shared different examples for building camaraderie among teams and empowering staff members to succeed in their roles. After a wide-ranging post-webinar Q&A session, Suzanne helped answer some attendee questions we weren’t able to address during the webinar.
What is growth prospective for a regulatory coordinator? What are the avenues you would suggest for a regulatory coordinator to grow in clinical research?
At our institution, we have a regulatory career path. We have staff who have started as research interns, worked as data specialists and are now on the career path towards regulatory. Inside our regulatory team, we have separate roles based defined by capabilities, skill and experience level. On a larger team, I can see the role of a senior regulatory coordinator evolving into a supervisor or regulatory manager who is directly overseeing the regulatory team as well as conducting internal regulatory audits and mock FDA audits at the site, and managing the action plans around potential findings.
How do you continue to show value to stakeholders – metrics, dashboards, reports, etc.?
The office of research presents to leadership each quarter on progress made on yearly goals. These include recruitment goals, compliance goals and revenue goals. The end of year report provides more detail in comparison to the previous year, including:
- How many subject visits were completed
- Staffing numbers
- How many subjects were recruited
- Number of studies opened and declined
- How many subjects were screened vs actually recruited
Can you talk more about how you convinced your group about the need for a more cohesive research group/team?
This ties back to seeing what other successful organizations similar to yours are doing to be great at clinical research. After attending many clinical research meetings, I started understanding the importance of diversity on the team and having certain employees specialize. When pressed for growth at my current organization, I was able to share the plan to increase the depth of the team similar to sites like ours who were recruiting more participants and running more studies with the same amount of people. It’s very important to know the research climate around you because you can use that to justify more personnel or a more diverse group. At the same time, if you are performing better than sites around you, it’s also important to capitalize on those strengths and provide this feedback to leadership.
Additionally, utilizing a workload tool directly showed leadership we were able to reduce a clinical research coordinators (CRCs) workload even when their study number and patient recruitment numbers, and therefore revenue, were increasing by removing the regulatory and data burden.
How do you perform audits or monitor/track productivity?
Internal audits are performed monthly for our high-risk areas identified by our compliance team. We perform research billing, informed consent, eligibility and regulatory audits monthly, setting goals for each of these areas. The audit responsibilities are spread out between several team members to lessen the burden of the internal audit. Trends in non-compliance are identified immediately this way and research team or individual training occurs as soon as possible after the finding of non-compliance. Quarterly, we report our findings (or lack thereof) to the compliance committee, so we are constantly held accountable by a higher committee to the standards we have set as a research team.
We also perform quarterly chart audits ensuring all research subject charts are organized and not missing data. The quarterly report is sent to each coordinator with a time frame for completing any missing fields or if deviations need to be reported to the IRB.
Productivity is tracked monthly by a workload tool developed for coordinators. Currently, I am not aware of a productivity tool for data specialists or regulatory coordinators. However, each monitor letter is reviewed by leadership in the research office and signed off by the principal investigator. Any issues identified in the areas of data management or regulatory compliance are addressed at the individual level with those team members. We also have bi-weekly meetings to track any findings which have been carried over for more than one monitoring visit until these issues have been resolved.
Besides growth for employees, do you have a bonus structure for your coordinators? Is it based on screening or follow up visits completed, number of errors made in a month, etc.?
As a non-profit organization, we do not have a bonus structure for coordinators individually. However, the organization does have an all-employee bonus which is based on meeting the organization’s overall revenue goal, and/or meeting at least two department goals and/or maintaining the values of our organization.
Could you provide the names of the books you mentioned in the webinar?
I would recommend any of the following:
- The 21 Irrefutable Laws of Leadership: Follow Them and People Will Follow You by John C. Maxwell
- The 17 Indisputable Laws of Teamwork: Embrace Them and Empower Your Team by John C. Maxwell
- The Five Dysfunctions of a Team by Patrick Lencioni
- The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change by Stephen R. Covey
- Lincoln on Leadership: Executive Strategies for Tough Times by Donald Phillips
- Serve to Lead: 21st Century Leaders Manual by James Strock
Additionally, I recommend any book by Atul Gawande.
Learn more about empowering your staff and leaders within an organization through promoting a positive work environment in the webinar “Developing Leaders and Building Successful Careers in Your Organization.”