Competency-Based Curriculum

Three of us (KC, LY, DS) worked with Bidwell Training Center to develop competency-based clinical research training to be incorporated within Bidwell’s Medical Assistant program. We chose the Medical Assistant program as the foundation for our START curriculum because students learn other skills during the 7-month program that are also essential for clinical research assistant positions, such as phlebotomy, electronic health records, vital signs, and patient interactions.

We drafted the START curriculum based on the main topics in four Collaborative Institutional Training Initiative (CITI) modules: Responsible Conduct of Research, Privacy and Information Security, Good Clinical Practice, and Human Subjects Research. Initially, the training comprised 2 weeks of pre-recorded presentations that the students watched, followed by the completion of homework assignments, and attending a remote meeting with the section presenters. Student were then asked to complete three CITI modules: Responsible Conduct of Research, Privacy and Information Security, and Human Subjects Research.

We received feedback from the students and the Medical Assistant Instructor at Bidwell Training Center that this was too time-consuming and dense. We therefore revised the didactic training for second cohort to cover eight sessions (Table 1) in six weekly classes, each lasting 2 hours. The students attended 1-hour remote lectures during which section presentations are delivered live, followed by questions and discussion. The program is currently delivered remotely using Google Classroom.

Table 1.

STricklAnd Research Training (START) program competencies

Instead of homework, short quizzes are given to check comprehension. Successful completion of the training is based on attendance, participation, quiz scores, a role-playing exercise, and – instead of CITI modules – completion of CIRTification Online: Community Involvement in Research Training [3], which is a free, interactive web-based human research protections training program tailored specifically for community research partners. This approach was better received by our second and third cohorts (Table 2) and will be continued going forward.

Table 2.

START program summary data

* Total number enrolled in Bidwell Training Center Medical Assistant program.

** Satisfactory completion of quizzes, role-playing, participation, CIRTification.

*** Externship agreement not yet executed at time of first cohort, no job opportunities as result.

Externship with mentoring and shadowing

A key component of all Bidwell programs is an externship, which must be unpaid per accreditation requirements. Students in the START program have the option of completing a clinical research-focused externship through the CTSI, during which students receive protocol-related training and mentorship. The importance of this type of hands-on externship for research staff is highlighted by recent findings that clinical research coordinators found experience, day-to-day practice, and observing colleagues and mentors an essential supplement to formal Good Clinical Practice training [Reference Mozersky, Antes, Baldwin, Jenkerson and DuBois4].

To enable START trainees to perform their externship at Pitt, an agreement was signed between the University of Pittsburgh on behalf of the CTSI and Bidwell Training Center. Externship experiences are study-specific and include shadowing in successful research programs and rotating through the CTSI Clinical and Translational Research Program sites, which provide specialized data collection and intervention services.

We also created a Memorandum of Understanding signed by CTSI and research groups interested in hiring a START program graduate as a research assistant. This Memorandum outlines expectations, including providing the START trainee with a hands-on externship opportunity, mentoring both through CTSI and the research program, and employment following successful completion of the externship. Although the externship is required to be unpaid, we were able to give START trainees vouchers for parking and bus fare.

We work with selected clinical research teams to create externships through which Bidwell students can learn and practice essential skills, such as recruiting patients for research studies, obtaining informed consent, and administering assessments. Because we specifically place students with research groups seeking to hire a clinical research assistant, the externship experience can also serve as initial job training and help ensure that the personnel fit is good. We plan to offer research teams participating in the externship bias reduction and other training in advance to ensure an inclusive, welcoming, and supportive culture and environment.

START externs must successfully complete CITI modules required for clinical research. Extern competencies are evaluated at weeks two and four of the externship, and, to date, all externs have passed their mid-review and final competency evaluations. Should a future extern have difficulty with one or more competencies tested, we would work with that START graduate and with Bidwell Training Center to adjust the externship to address the needed competency.

Transition to employment

As noted above, students are matched with a clinical investigator who has a research assistant job opening, with the intention that the externship will transition to full employment at Pitt. Working with the clinical study team as part of their formal training ensures START trainees are fully aware of what is expected of them when they are hired. At the same time, clinical investigators are briefed in advance about their expectations for START program students, since they do not come from an undergraduate background like most clinical research assistants.

A Workforce Development Career Counselor in Human Resources works with the START program students to help them prepare, submit, and track their job applications. The counselor can also help ensure the applications are reaching the research teams.

Career advancement

Research staff at all career stages have professional development opportunities through CTSI, and all employees at Pitt receive tuition benefits that would allow START graduate hires and their spouses and children to pursue college degrees. The Pitt College of General Studies offers a variety of learning options designed for adult and non-traditional students and includes flexible scheduling for those who work full-time.

Research teams who hire START graduates are specifically asked to give these research assistants time off to attend the CTSI Introduction to Research Workforce activities, which includes the 2-day Orientation to Research Fundamentals workshop offered semi-annually, as well as CTSI Diversity, Equity, and Inclusion trainings. In addition, we offer more advanced workshops and trainings throughout the year that START hires can complete to document new skills that could qualify them for salary increases. Following hire, the START program coordinator routinely checks in with the START graduate to provide mentoring and support as they transition into their new role as a clinical research assistant.

Program enrollment

Students enroll in the Bidwell Medical Assistant program and then learn about the START training. Since November 2020, three cohorts have completed the START program (Table 2). The first cohort had lower enrollment numbers than is typical for the Bidwell Training Center due to the COVID-19 pandemic; typical class size is 14–20. Due to a delay in executing the externship agreement, Pitt was not able to host the first cohort of externs after they completed their START training.

All 14 students in the second cohort successfully completed both the medical assistant and START training. All four students who chose to complete their externships through CTSI had the opportunity to apply to open research assistant positions at Pitt. Three out of the four applied and were offered positions, and one student accepted the job offer at Pitt; one of the other students initially decided not to accept the offer but later came back to apply again and has been hired. In the third cohort, four START trainees completed their externship through CTSI. Two pursued clinical research assistant jobs at Pitt, while the other two students decided to pursue other careers.

To date, START graduates hired at Pitt have been majority female and older (>51 years), and half (2/4) are Black. Table 3 provides quotes from START externs and hires on why they did or did not pursue a career in research and, for current hires, their experience.

Table 3.

Qualitative feedback on decision regarding research career

Future plans

We are evaluating the success of the program itself quantitatively and qualitatively. At the conclusion of the didactic training and again at the conclusion of the externship, Bidwell students complete an evaluation form, and their feedback is used to improve the START program.

For those hired at Pitt, we will monitor whether START graduates remain in research assistant positions at Pitt longer than more traditional hires with college backgrounds, since the START research assistants may be more likely to view their positions as career opportunities with room for advancement. We will also monitor whether they pursue a college degree on a career path to become a biomedical researcher.

We will similarly evaluate the quantitative (e.g., enrollment-retention of study participants from underrepresented backgrounds) and qualitative (e.g., team perspectives on inclusion and awareness of bias) impact of START graduates on the clinical studies and the research teams in which they are involved.

To enhance retention, we will create a near-peer mentoring program partnering START program hires with experienced research staff. The near-peer mentor will be trained by Master Facilitators at Pitt who are certified in teaching the Entering Mentoring curriculum [Reference House, McDaniels, Spencer, Utzerath and Pfund5]. The near-peer mentor will meet with their START mentee monthly or more frequently if needed.

To support career advancement, we are working closely with Human Resources and the Office of Diversity at Pitt to create a competency-based structure for research staff that can be used for hiring, promotion, and compensation. In collaboration with the Duke CTSA Hub, we are adapting for use at Pitt their REDCap tool to identify job classifications based on competencies. Duke’s tool enables faculty to identify potential staff and list the job responsibilities for that role, and then map the role to a job title [Reference Brouwer, Deeter and Hannah6,Reference Stroo and Deete7]. The program creates a professional pathway, identifies advancement opportunities, and defines objective assessments of competencies needed for advancement. In parallel, we will adapt our online Customized Career Development Platform to enable research staff to strategically plan their careers by identifying career goals and linking competency-based training that is available at Pitt or nationally to each goal. This competency-based pathway for career advancement will help START Program hires clearly understand what they need to learn or accomplish to be eligible for a step increase in salary within their job classification, and CTSI will be available to help them track progress and achieve these goals.