Clinical Researcher—November 2019 (Volume 33, Issue 9)

PEER REVIEWED

Zoe Davies, NP, MS, CCRC; Colleen Dunn, MS, RRT, CCRC; Elizabeth Hartigan, MPH, RN, CRM; Kathleen Hilliard, CCRC; Patricia Burks, RN, MA, CCRC

Cystic fibrosis (CF) is an inherited, autosomal recessive, multisystem disease that affects approximately 30,000 individuals in the United States{1} and is caused by mutations in the gene that produces the CF transmembrane conductance regulator (CFTR) protein. CFTR is chiefly responsible for the transport of ions and fluid across epithelial cell membranes, such as those found in the lung, pancreas, liver, gastrointestinal tract, and skin. The abnormalities in the lung lead to airway obstruction, inflammation, and infection, which cause progressive airway damage and account for most of the morbidity and mortality seen in CF.{2}

Huge advances have been made in recent years in the knowledge about the defective gene that causes CF, its defective protein product, and the downstream clinical consequences for people with CF. This, in turn, has led to the development of multiple therapies which have improved the mean life expectancy for a person with CF to approximately 44 years of age.{1} These advances are the result of successful clinical research efforts supported, in part, by the Cystic Fibrosis Foundation (CFF).{3}

In collaboration with industry and academic partners, the CFF has developed a robust drug development pipeline to meet the overall mission of improving the lives of patients with CF. Key limiting factors to moving multiple therapies forward simultaneously have included both recruitment of subjects (since CF is considered an “orphan disease” that affects less than 200,000 people nationwide) and the availability of trained clinical research staff.{3} Recognizing this need, the CFF founded the CF Therapeutics Development Network (TDN) in 1998.{3}

The CF TDN was initially comprised of eight clinical research centers, but over the years it has expanded to its present total of 92 centers.{4} The development and expansion of the CF TDN has helped to ensure broad geographic distribution of CF clinical research centers across the United States, thereby increasing access for many additional eligible CF patients. As these new centers have been added to the network, a key goal has been to ensure that each one has dedicated, well-trained CF researchers—particularly clinical research coordinators (CRCs)—available to conduct the research.

Additionally, CRC turnover and retention are important issues facing most research programs, regardless of clinical indication. According to a 2017 survey conducted by SCORR Marketing,{5} 41% of research professionals are considering switching jobs and don’t see much opportunity for career advancement within their organizations. Prior to 2008, CRC turnover in the CF TDN was believed to be due to the length and complexity of many of the CF research protocols, which often require specialized training; the long, often tedious working hours; the lack of career advancement; and less than optimal pay. To a new CRC, these issues can be overwhelming.

Recognizing the crucial role of the CRC, the CFF decided to pilot a CF CRC mentoring program modeled after a similar program developed for CF dieticians. The main goals of this program were to provide resources, training, and networking opportunities to those new to the CF research world, with the hope of increased retention of those same CRCs over time.

Program Description{6}

In 2008, this program consisted of four keys roles (see Figure 1 in the full-issue PDF of this issue for a visual representation):

Team Leader—This person provided oversight for the entire mentoring program. The team leader coordinated all activities related to the program and served as a conduit between the CFF and the TDN. This person also helped to develop the materials needed for the program and facilitated conference calls, site visits, and e-mail contacts.

CF CRC Facilitator—The facilitators served as the organizational conduit between the mentors and the apprentices. They helped to develop and oversee the mentoring curriculum and made sure that the mentors and apprentices were “a good fit” for each other. Interactions included face-to-face meetings, site visits, phone, and e-mail contacts.

CF CRC Mentor—Served as a resource for new CF RC apprentices. The interactions included a face-to-face meeting, a site visit from the apprentice to the mentor’s site, phone, and e-mail contacts for at least three months after the site visit.

CF CRC Apprentice—Individuals who were new to CF research and who intended to continue in CF research after program completion.

Today, the organizational structure remains much the same with one exception: The two facilitators absorbed the team leader position/responsibilities in 2013.

History

The rollout of the program was initially announced at a national CF CRC retreat as well as advertised on the CF CRC TDN website. Individuals for the first group of mentors were handpicked by the CF mentoring program executive committee (the team leader, facilitators, and a representative from the CFF and TDN), and those interested in being an apprentice were required to fill out an online application. The team leader and facilitators matched the available mentors to apprentices depending on various criteria; for example, patient population (adult, pediatric, or both), the specific type of experience needed, and geographical location.

The facilitators then contacted the mentor/apprentice pairs to notify them of the match as well as help to “facilitate” the overall mentoring experience. Each mentor contacted his or her apprentice to determine the specific learning needs, help develop goals and objectives, and set up a date for the site visit. Once the site visit was over, the mentor and apprentice as well as the apprentices’ principal investigators (PIs) were required to complete an evaluation of the process. The mentor was also required to maintain contact for three months following the visit to provide additional support as needed.

After the apparent success of the first group of CRC apprentices in 2008, it became a regularly scheduled program offered to new CRCs within the TDN network once or twice per year. As each cohort of mentors and apprentices completed the program, any issues that had occurred during that particular match period and the post-visit evaluations were reviewed and discussed by the program leadership. This provided important feedback, which was used to update and improve the overall program; for example:

A web-based application process using Survey Monkey is now the method that both apprentices and mentors use to apply to the mentoring program, as well as for completion of the post-visit evaluations.
Application questions were streamlined and/or rewritten to better identify “best” candidates.
Post-visit evaluation questions were modified in order to better understand the individual’s experience.
PI awareness and engagement is crucial for the success of the program; now they are involved from the beginning of the application process through program completion.
To fine-tune presentation and lecturing skills, apprentices are required to present their goals and objectives, as well as a mid-and post-visit summary, to the group.
Program documents, power point presentations reviewed and updated on a yearly basis.
Added specialty mentoring tracts (i.e., program management, regulatory, and laboratory).

In Retrospect

After 10 years of program implementation, a retrospective review was completed to ascertain if the program was indeed providing the necessary support, resources, and training to participants. All of the post-visit evaluations obtained from the apprentices, mentors, and PIs from 2008 until 2018 were sorted and reviewed. As edited for clarity and listed below, the questions required either open-ended, best answer, or yes/no responses (see Figures 2, 3, and 4 in the full-issue PDF version of this article for highlights from the responses).

Apprentice

The CF CRC mentoring program met my expectations.
The CF research program has improved at my center since I participated in the mentoring program.
I feel I am more knowledgeable and active in CF research since I participated in the mentoring program.
Please briefly describe the site visit, explain what the focus of the visit was, and provide examples of what you took away from the visit.
Do you feel that you were adequately prepared for the visit?
After the site visit, please list any processes/changes you would like to incorporate at your center to improve site performance.
After consultation with your mentor regarding clinical trial and site management processes at your site, describe the focus of your interactions with your mentor or your learning plan.
Name a tool from the CF ClinicalResearchNet Toolkit (see * below) that you were able to implement at your center.
What do you consider the most positive change you have made in your research program as a result of the CRC mentoring program? (see ** below)

*The toolkit contains numerous “tools” specifically for the CF CRC. The most commonly implemented tool(s) included the templates and checklists for facilitating study startup and the site budget tool to help create appropriate study budgets.

**Participating in the program helped apprentices better identify areas for improvement at their own sites, improved their overall communication skills, and facilitated networking with their colleagues.

Mentor

The CF CRC mentoring program met my expectations.
Were interactions with the facilitators helpful?
Please briefly describe the site visit and what the focus of the visit was.
Do you feel that you were adequately prepared for the visit?
After the site visit, list three things that you think would improve performance at the apprentice’s site.
After consultation with the apprentice regarding clinical trial and site management processes at their site, describe the focus of your interactions or your learning plan.
Name a tool from the CF ClinicalResearchNet Toolkit that your apprentice was able to implement at his/her center.
I think the CRC mentoring program makes a difference in the CRC community at large.

The CF CRC mentoring program met the expectations of the CRC at our site.
The site visit provided our CRC with more knowledge in CF research.
Have you and your CRC identified a process that you intend to evaluate and improve?
Have you and your CRC been able to make a plan to address improvement changes?
List the new tools your site CRC has been able to implement at your center.
List changes noted in your research program since the CRC at your site participated in the mentoring program.
Was there an impact on the partnering between the PI, clinic nurse/coordinator, and CRC at your site after your CRC participated in the mentoring program?
Fostering leadership skills was an inherent part of the mentoring program. Have you witnessed an enhancement in this since your CRC participated in the program?
What project(s) is your CRC planning to work on over the next year?

Apprentice Comments

“Thank you so much for the opportunity to participate in the [mentoring program]. As a coordinator new to research entirely and the only CF research person at my site, this program has showed me how supportive and helpful the CFF/TDN community is and their commitment to fostering growth as coordinators.”

“I am so thankful for being given this opportunity by the TDN. I will forever be grateful for the people I met in this program and for everything I’ve learned that I will take with me throughout my career.”

“I had a wonderful experience and am grateful for the opportunity. My mentor is very knowledgeable and admirable. I’m certain this program contributed to improved performance of research for me, individually, and for our center.”

Mentor Comments

“I love this program and the opportunity to network with new coordinators. They give me energy and new ideas. Thank you for the opportunity.”

“What a wonderful program. We were able to connect at NACFC and sit in sessions together. We have continued our mentor relationship, talking briefly at least [monthly], sharing concerns [and] milestones, and having opportunity for learning from each other.”

PI Comments

“I felt the program to be extremely valuable. I hope the [mentoring] will continue in the future.”

“Nancy, our new [coordinator], has taken huge initiative to move our CF research program forward. We couldn’t do it without her.”

“My [coordinator’s] mentor spent the day with her then disappeared to who knows where. Thus [she] never received any of the helpful handouts, spreadsheet formats, etc. that the mentor had promised her. Disappointing.”

Status Update

By the end of 2018, 102 apprentices had completed the program: 53 (52%) of those individuals are still working as CF CRCs and 49 (48%) have since left the position. Eight (7.8%) of those apprentices eventually became mentors. There were 50 mentors, 35 (70%) of which are still in CF research and 15 (30%) of which have since left the position.

Conclusion

The data show that the vast majority of participants feel that the mentoring program is indeed a worthwhile endeavor providing new CF CRCs with tools, ideas, and support for increasing their CF knowledge base and helping make their jobs more manageable. CRC turnover continues to be an issue, but once a CRC becomes a mentor, he or she seems more likely to remain in CF research.

In September 2016, in order to track turnover rates and determine the common reasons for leaving, the TDN decided to initiate CRC exit interviews. At the time of article submission, there were 71 completed interviews. CRCs indicated issues with coworkers and supervisors, pay, and lack of career advancement as influencing their decisions to leave the job. Interestingly enough, the length and complexity of protocols and the long, often tedious working hours were not significant issues. Mentors left their positions mainly due to retirement or career change/advancement within their institutions.

Obviously, continuing to obtain post–apprentice visit surveys as well as completing CRC exit interviews will be important to help with mentoring program development, which in turn will hopefully help improve overall job satisfaction and retention amongst CF CRCs.

Acknowledgements

The authors would like to thank Jill Van Dalfsen, BS, for her review and helpful suggestions for the manuscript, Mary Elizabeth Jarosz, MSPH, RD, for statistical support, and Alyssa Remulla, MPH, for help with the figures prior to submission.

References

Cystic Fibrosis Foundation Patient Registry. 2017 Annual Data Report to the Center Directors. Cystic Fibrosis Foundation; Bethesda, Md.
Bush A, Alton EWFW, Davies JC, Griesenbach U, Jaffe A. 2006. Cystic fibrosis in the 21st century. London: C.T. Bolliger.
Davies Z, et al. Quality improvement projects improve patient recruitment and participation in five cystic fibrosis research centers. The Monitor 25(4):43–7.
Hoffman A. 2019. Competitive renewal. The TDN Times 10(1):5.
Clinical Research Industry Salary and Employee Satisfaction Survey Report. 2017. https://www.scorrmarketing.com/resources/salary-survey-report/
Cystic Fibrosis Foundation. 2008. Cystic Fibrosis Research Coordinator Mentoring Program Phase 1: Information Sheet.

Zoe Davies, NP, MS, CCRC, (zdavies@stanford.edu) is on the research staff with the Stanford Cystic Fibrosis Center in Palo Alto, Calif.

Colleen Dunn, MS, RRT, CCRC, is the clinical research manager of the Stanford Cystic Fibrosis Center in Palo Alto, Calif.

Elizabeth Hartigan, MPH, RN, CRM, is a clinical research manager at Children’s Hospital of Pittsburgh of UPMC in Pennsylvania.

Kathleen Hilliard, CCRC, is a director of clinical research operations with Rainbow Babies and Children’s Hospital in Cleveland, Ohio.

Patricia Burks, RN, MA, CCRC, is director of clinical trial affairs with the Cystic Fibrosis Foundation.

ACRP Learning Update

Cystic Fibrosis Clinical Research Coordinator Mentoring Program: A Review