Clinical Researcher—April 2022 (Volume 36, Issue 2)

PEER REVIEWED

Demi Beckford, MHS; Kelly Boone, MA, CCRP; Jessica Fritter, MACPR, ACRP-CP; Grace Wentzel, CCRP, CHRC

Nationwide Children’s Hospital has an expansive clinical research portfolio that has continued to increase in number and complexity over the last five to seven years. As this has occurred, the number of clinical research staff being hired across the organization has steadily increased to approximately 2,100 in the last five years. With such a large group of clinical research professionals, a program to serve as a central point for staff to connect and obtain resources became essential. This led to the creation of Bloom: Clinical Research Professionals Group (Bloom).

Bloom is one of two initiatives under the hospital’s Research Matters committee, which is managed in the Abigail Wexner Research Institute and is overseen by the Director of Safety and Training. The mission of Research Matters is to serve as a resource to the hospital and research institute community, including patients and families, on issues related to both basic science and clinical research activities.

The other initiative under Research Matters is the Research Institute Diversity Enrichment (RIDE), with a mission to engage the research community through education, celebration, and promotion of diversity. Bloom and RIDE work in tandem across the organization.

Bloom was established in 2020 with the purpose of building a network of clinical research professionals and providing a space to collaborate, receive education and training, and find mentors/mentees within a large pediatric academic medical institution that integrates both a free-standing pediatric hospital and a dedicated research institute. Bloom is overseen by the Director of Clinical Research Services. Bloom does not have an operating budget; however, there are some internal funds that Bloom can utilize.

Bloom leadership consists of research-affiliated departments across the hospital, including Hematology/Oncology/Blood and Marrow Transplant, Clinical Research Services, and the Behavioral Trials Office. There are three main positions within the Bloom steering committee: Program Chair, Education and Activities Coordinator, and Administrative Coordinator. The steering committee has a rolling membership of two years for leadership roles within the program.

The leadership aims to strengthen and enhance the clinical research community by connecting its professionals and providing them with resources and opportunities to discuss timely topics, address knowledge gaps, and expand the community. The goal of Bloom is to create a sense of belonging within the organization and foster retention. Currently, there are very few instances in the literature discussing how and why to build and maintain a group for institutional research professionals like Bloom.

Our objective in this article is to describe the baseline characteristics and needs of members as well as the structure of Bloom. We discuss the benefits of the group and conclude with how an institutional group for clinical research professionals can develop, enhance, and strengthen an institution’s clinical research community.

Methods

In collaboration with our project managers, the authors designed two surveys (a baseline/interest survey and the first annual member survey for the conclusion of Bloom’s first year of activity) to distribute among clinical research employees.

The baseline survey included 12 items and was distributed through multiple channels, such as employee engagement e-mail lists and employee news e-mail lists. The baseline survey asked for employment (e.g., years in clinical research, job title) and demographic (e.g., education level, clinical research certification) information. It also asked what educational topics, speakers, and/or service opportunities members would like to see facilitated through Bloom.

In addition to gathering baseline data, the survey obtained e-mails, and thus prompted an e-mail list that enabled efficient and timely distribution of information on Bloom events and research-related policies (e.g., COVID updates). Summary statistics describing employment and demographic characteristics and broad themes were identified to summarize engagement opportunities of interest to members (see Appendix A).

Those who completed the baseline survey and became members of Bloom were then given a 16-item survey which was distributed via e-mail one year after the inception of the group (see Appendix B). This consisted of questions regarding professional certification and job promotion status within the previous year. There was a section for open comments to facilitate suggestions for group resources and networking opportunities.

The survey tool used was Research Electronic Data Capture (REDCap) software. Under 45 CFR 46.101 in the Code of Federal Regulations, the Nationwide Children’s Hospital Institutional Review Board was able to exempt the survey tool. The survey was live for five weeks and results were downloaded from REDCap for analyses. Data were analyzed using summary statistics.

The first annual member survey was distributed to clinical research staff who were members of Bloom during the winter of 2021. Group members consist of research professionals from three categories: Abigail Wexner Research Institute at Nationwide Children’s Hospital, other areas of Nationwide Children’s Hospital, and The Ohio State University Medical Center. The questions focused on demographics, site-specific training, job titles, research professional certification, promotions, content of meetings, skill level, and open comments/suggestions. Using a five-point Likert scale, participants were asked to rate the competencies obtained during Bloom sessions from “strongly disagree” to “strongly agree” (see Figure 1).

Figure 1: Likert Scale One-Year Survey Responses

Results

The baseline/interest survey had 172 respondents across a variety of clinical research roles: 72% Clinical Research Coordinators (CRCs), 9% Research Managers, 8% Investigators, 3% Research Assistants, 5% Research Administration, and 3% Data Analysts/Managers (see Figure 2). The median length of time engaged in clinical research was three years (with a maximum of 37 years), with 26% of respondents starting employment at the institution within the past year. More than half (52%) of respondents were research institute (vs. hospital) employees. Five percent had an associate degree or lower, 56% had a bachelor’s degree, 22% had a master’s degree, and 17% had an MD or PhD. At baseline, only 17% of respondents had a clinical research certification, but 83% of those who did not have this credential were interested in pursuing a certification.

Figure 2: Group Membership Role Breakdown

Broad themes that emerged in terms of what members would like to gain from involvement in the group include topics related to clinical research operations (33%); professional development and education (26%); professional networking opportunities (23%); study design, writing, and analysis (17%); and clinical research certification and maintenance (15%) (see Figure 3). Topics of interest were not associated with years in clinical research.

Figure 3: Broad Theme Topics

For the first annual member survey, 47 of 172 recipients responded (27%). Within one year from the creation of the program, Bloom supported fees associated with obtaining a clinical research certification for five members. Two members were promoted (Research Regulatory Coordinator to Research Regulatory Specialist; CRC I to CRC II). Almost three-quarters (74%) of respondents indicated that Bloom provided networking opportunities and 70% thought that the content of the meetings/seminars were useful. Sixty-one percent indicated that the group enhanced their professional development.

Discussion

At its conception, Bloom was structured to host a monthly meeting with themes relating to researcher spotlights, educational topics (continuing education credits provided), and networking and service opportunities. Sub-groups were also created called People Like Me groups, which consisted of research professionals with similar titles and responsibilities. The purpose of these groups was to engage, support, and provide resources to members by holding quarterly meetings to enable networking within the organization.

Bloom meetings began in May of 2020 during the early days of the COVID-19 pandemic. This affected the structure of the group and its ability to host in-person networking functions. All in-person meetings and events were reformatted to virtual, with the highest attendance rate being 74% and an average attendance rate of 52%. As a result of no in-person meetings or events, we measured the group’s effectiveness by relying heavily on virtual meeting interactions and survey responses.

We used feedback received in the first annual member survey to determine the 2022 schedule. This includes more in-person networking opportunities (as COVID-19 allows), a clinical research speaker series, and more in-depth discussions surrounding grant management, diversity/inclusion trainings, and other appropriate topics. A monthly newsletter will also be implemented to further integrate different areas of research. This newsletter will include current research job openings, relevant research trainings and seminars from other organizations, as well as departmental spotlights to increase collaboration.

Initiatives offered through this group benefit the clinical research community by facilitating interdisciplinary collaboration, with the aims of achieving optimal results and increasing organizational efficiency and compliance.

Limitations

One limitation to this study is that the outcomes rely on self-report. In addition, although this survey captured respondents from three different categories of employment, our results may not be generalizable because only 27% of members responded. Another limitation is due to the COVID-19 pandemic guidelines; these guidelines prohibited the group from conducting some 2020 and 2021 agenda items that were set prior to COVID-19. These events included meeting in person to provide further networking/hands-on learning opportunities, which may have affected the survey responses.

Conclusion

Clinical research professionals at a large pediatric academic medical center are eager to find a space to connect with their colleagues across the institution, regardless of years in the profession. To fill this gap, we created a group that offers regular steering committee meetings, speaking engagements, and educational sessions, it also provides various networking opportunities and financial and educational support to obtain/maintain a clinical research certification. Collectively, initiatives offered through this group benefit the clinical research community by facilitating cross-cutting collaboration, with the aims of achieving optimal results and increasing organizational efficiency and compliance. This group will continue to develop by enlisting new members and conducting routine follow-up surveys to gauge the relevance of provided sessions, as well as to identify needs of members.

Acknowledgement

The authors wish to thank Katie Campbell for her continued support of the Bloom: Clinical Research Professionals Group.

Editor’s Note: In between the acceptance of this article for publication and its appearance online, Bloom was rebranded as Children’s Hospital Clinical Research Professionals (CHIRP).

References

U.S. Department of Health and Human Services. 45 CFR 46. http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/
Wentzel G, Fritter J. 2021. ACRPtv Spotlight On… The Benefits of an Institutional Clinical Research Professionals Group. https://acrpnet.org/2021/03/02/acrptv-spotlight-on-the-benefits-of-an-institutional-clinical-research-professionals-group/
Jones C, Kesling B, Fritter J, Neidecker M. 2020. How to Begin a Career as a Clinical Research Professional. Clinical Researcher 34(6). https://acrpnet.org/2020/06/09/navigating-a-career-as-a-clinical-research-professional-where-to-begin/

Demi Beckford, MHS, (demi.beckford@nationwidechildrens.org) is a Planning and Business Development Project Manager for CONNECT – NeuroOncology Clinical Trials at Nationwide Children’s Hospital in Columbus, Ohio.

Kelly Boone, MA, CCRP, is Associate Director of the Behavioral Trials Office in the Center for Biobehavioral Health at the Abigail Wexner Research Institute, Nationwide Children’s Hospital.

Jessica Fritter, MACPR, ACRP-CP, is Clinical Research Administration Manager with the Department of Clinical Research Services at Nationwide Children’s Hospital.