Conceptual framework

The University of Florida (UF) and Florida State University (FSU) CTSA hub initiated the program. The Analysis, Design, Development, Implementation, and Evaluation (ADDIE) instructional design model [Reference Branch14] guided program logic model inputs, activities, outputs, expected outcomes, impacts, and evaluations, with iterative refinement across cohorts based on cohort feedback (Supplementary Materials 1). See Figure 1 and Supplementary Materials 2 for program overview and supporting documents.

Figure 1.

Mentoring program logic model.

Figure 1. Long description

The figure presents a logic model for a hybrid clinical research mentorship program. Inputs include a needs assessment, the ADDIE instructional design framework, program leadership, mentors, Microsoft Teams, educational resources, and institutional support. Activities include recruitment, mentor-mentee matching, monthly mentoring sessions, professional development workshops, and networking through Microsoft Teams. Outputs include mentoring groups, sessions, workshops, resource utilization, and participant engagement. Program evaluation uses the Kirkpatrick Model to assess participant reaction, learning, behavior change, and results. Expected outcomes include increased clinical research knowledge, mentoring skills, confidence, professional networks, and collaboration. Long-term impacts include professional development, leadership growth, career advancement, workforce retention, a sustainable mentoring culture, and strengthened workforce capacity.

Analysis phase

During the Analysis Phase, the CTSA hub Translational Workforce Development (TWD) leadership team identified learner needs, defined the target audience, and established learning goals using national CRP workforce survey results and an institutional CRP needs assessment survey [Reference Carey, Dunn and Braxton3,Reference Cagnazzo, Testoni and Speranza4,Reference Stroo, Reyes and Deeter6,Reference Townsend8]. National and institutional findings identified coordinators as the majority of respondents with identified mentorship, peer networking, community building, and role-specific, relevant training as priority needs for coordinators working within a decentralized AHC environment [Reference Carey, Dunn and Braxton3,Reference Cagnazzo, Testoni and Speranza4,Reference Townsend8].

Following a literature review, the TWD leadership team sought the feasibility of a competency-based mentoring program within our CTSA hub environment [Reference Cranfill, Deeter, Hannah, Snyder and Freel2,Reference Nelson, Dunn and Levites Strekalova9,Reference Samuels, Champagne and Lyden15–Reference Jones, LIU, Hornung, Fritter and Neideker17]. Targeting this CRP audience and the relevant identified learner needs, a pre-program feasibility interest survey was distributed via the CTSA hub Coordinator Email ListServ to assess interest in the program and the feasibility of recruiting volunteer mentors, with the subject line, “Gauging Interest from UF + FSU CTSA hub CRCs in Participating in a Pilot Coordinator Mentoring Program.” The email explored preferences in mentor models, program length, preferred institutional platform (Microsoft Teams vs. Canvas), orientations, mentoring goals and training needs, preferred PD topics and resources, research areas and funding mechanisms, networking preferences (in-person versus hybrid), and the coordinator’s usual scheduling availability [Reference Nelson, Dunn and Levites Strekalova9–13].

Design phase

Based on findings from the Analysis Phase, a structured six-month hybrid mentoring model was developed for coordinators, incorporating elements of group mentoring and peer co-mentoring circles [Reference Nelson, Dunn and Levites Strekalova9,10]. Program goals included building mentoring relationships, strengthening knowledge, skills, and confidence (KSC) in the coordinator role, expanding professional networks, and promoting a supportive interinstitutional clinical research community to improve job satisfaction and retention [Reference Nelson, Dunn and Levites Strekalova9,Reference Samuels, Champagne and Lyden15–Reference Pfund, Byars-Winston, Branchaw, Hurtado and Eagan18].

The program focused on five areas: (1) creating small mentoring groups led by co-mentors; (2) strengthening competencies by integrating content from the Center for the Improvement of Mentored Experiences in Research (CIMER) curriculum [13] and the Joint Task Force for Clinical Trial Competency (JTF) framework [12]; (3) supporting professional networking and career development [Reference Lee-Chavarria, Loucks and Paranal7,Reference Nelson, Dunn and Levites Strekalova9]; (4) encouraging peer learning and community building [Reference Cranfill, Deeter, Hannah, Snyder and Freel2,Reference Carey, Dunn and Braxton3]; and (5) promoting continued PD through reflection, discussion, and practical skill-building activities [Reference Samuels, Champagne and Lyden15–Reference Pfund, Byars-Winston, Branchaw, Hurtado and Eagan18].

Microsoft Teams 365 Classroom (Microsoft Corporation, Redmond, WA) was selected based on the availability of technology across participating institutions and coordinator preferences identified in the Analysis Phase, thereby enabling support for a geographically distributed workforce through a single, secure platform that serves as the program hub for communication, resource sharing, and ongoing engagement [Reference Lawson, Barros, Evans and Saleem11].

Based on the program design, the TWD leadership identified the institutional resources, software, and personnel needed to develop, implement, and sustain the program, including program administration, mentor support, workshop coordination, evaluation, and reporting, and budgeted 0.25 FTEs for a TWD leadership administrator. Access to survey development and management tools, such as Qualtrics (Provo, UT) and Canva (Sydney, Australia), was used to build resources, including checklists, PowerPoint presentations, and visuals. Credly digital badges (Credly by Pearson, New York City, NY) were used to distribute badges.

Development phase

During the Development Phase, the TWD leadership administrator built the Microsoft Teams platform, curricula, Qualtrics program surveys, Microsoft Forms workshop satisfaction surveys, and supportive resources designed in Canva and aligned with the JTF competency framework and CIMER curricula [12,13,Reference Samuels, Champagne and Lyden15–Reference Hyun, Rogers, House, Sorkness and Pfund19]. Initial workshop presenters were identified and vetted for the proposed workshop content and topics. Credly digital badges were created for mentees, mentors, and presenters who participated in the program. The Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) were contacted to obtain approval for PD workshops that offer continuing education hours for recertification [20,21].

Senior CRPs and TWD leadership team validated the platform, curricula, assessments, and resources to support consistent but scalable cohort delivery and to ensure they reliably reflected relevant coordinator responsibilities, program objectives, and CTSA hub TWD priorities [Reference Carey, Dunn and Braxton3,Reference Pfund, Byars-Winston, Branchaw, Hurtado and Eagan18].

Implementation phase

The Implementation Phase includes participant-facing activities before program launch, including recruitment, mentor group matching, mentor onboarding, orientation, and program activities completed during the six-month program: (1) monthly co-led mentoring group meetings, (2) monthly PD workshops, and (3) utilization of a Microsoft Teams digital collaboration platform [Reference Cranfill, Deeter, Hannah, Snyder and Freel2,Reference Carey, Dunn and Braxton3,Reference Nelson, Dunn and Levites Strekalova9,Reference Lawson, Barros, Evans and Saleem11].

Participant recruitment

Recruitment occurred two to three months before the cohort launch using a Qualtrics registration survey titled, “Sign Up for the Pilot CRC/CRN Group Mentoring Program.” The program was promoted through CTSA hub listservs, email announcements, website postings, and colleague referrals. Coordinators involved in clinical research activities across the CTSA hub were eligible to participate, including those engaged in regulatory activities, participant recruitment and informed consent, protocol implementation, study coordination, and data management [Reference Cagnazzo, Testoni and Speranza4,12,Reference Samuels, Champagne and Lyden15]. Interested individuals completed the registration survey, which included participant demographics, research experience, research focus, funding sources, preferred program role (mentor or mentee), and preferred mentor group. Information collected during the registration and preference surveys supported mentor-mentee matching and mentor group placement. During recruitment, the TWD leadership team shared program objectives, expectations, and participation requirements. Individuals who expressed interest after enrollment closed could still join the cohort during its first month, provided they completed registration and onboarding activities.

Mentor vetting

Coordinators interested in serving as mentors identified this preference during registration and completed a telephone interview to discuss prior mentoring experience, role expectations, and areas where additional support may be helpful. Individuals with previous mentoring or leadership experience were preferentially selected as co-lead mentors.

Mentor group matching

Groups consisted of two co-lead mentors and three to six mentees, with group size anticipated to vary across cohorts. Registration survey responses were used to create mentoring groups. Whenever possible, participants were matched based on shared research or clinical focus areas, including department affiliation, clinical disorders, disease specialty, and study type; experience level; mentor availability; and participant preferences for exploring research areas outside their usual practice [Reference Samuels, Champagne and Lyden15–Reference Jones, LIU, Hornung, Fritter and Neideker17].

Once groups were organized and mentor vetting completed, an additional preference survey was administered to all participants, including (1) group assignments, team members, research focus, and (2) cohort topic requests. In this preference survey, participants reviewed their pre-cohort group-mentoring matching assignments and had opportunities to submit change requests. The cohort topic requests included JTF and CIMER content, which were tabulated per cohort for PD workshop curricula and per group for co-led group meeting curricula [12,13].

Mentor onboarding

Mentors participated in two additional onboarding sessions in the month prior to the cohort launch, resulting in a seven-month commitment from mentors. Onboarding activities included program expectations, mentoring using the CIMER Entering Mentoring curriculum [13], partnering with a co-lead, establishing mentoring relationships and communication pathways, facilitating a mentoring group and adapting to group dynamics, creating a JTF-aligned lesson plan and group-specific activities to enhance skill application [12], reviewing competency-based mentoring resources, and reviewing use of the Microsoft Teams platform. Mentee’s per-group registration surveys and PD topics were distributed to co-lead mentors, and group meeting lesson plans and activities were created by mentors prior to program start and supported by the TWD leadership administrator [12,13]. A Microsoft Teams mentor channel was used to provide a designated space for mentors to ask one another questions and share resources and activities.

Orientation and office hours

During the first month, all cohort members participated in an orientation and meet-and-greet that covered mentoring program expectations, mentor and mentee roles, CIMER and JTF competencies, expected cohort and group activities, and Microsoft Teams navigation. The TWD leadership administrator provided weekly virtual office hours to assist with program questions, concerns, technology access, platform and research navigation, and related topics.

Co-led monthly group mentoring meetings

Experienced co-lead mentors, assigned to small groups of mentees, established a monthly schedule and group expectations with their mentees and met for 30–90 minutes each month for six months. Mentors started each cohort with a structured lesson plan and adapted throughout the cohort based on their group’s ongoing needs. Meetings supported competency-based activities, reciprocal learning, discussion of workplace challenges, best-practice sharing, and collaborative problem-solving specific to their group research areas and workflows [12,13]. Mentors were encouraged to adapt research-specific activities to their group’s research focus, experience level, and learning needs. As groups matured, mentees were cultivated to lead discussions and share insights with peers [Reference Pfund, Byars-Winston, Branchaw, Hurtado and Eagan18].

Professional development workshops

Participants engaged in monthly 60–90-minute competency-based, role-relevant workshops throughout the program [12,13]. Workshop topics were selected based on cohort-specific preferences. Workshops were designed to support workflows, skill application, and confidence through developed clinical research practices, including protocol adherence, team dynamics, audit readiness, study operations, and regulatory processes [12]. Experienced CRPs and institutional experts were selected based on their demonstrated leadership in clinical research operations, regulation, administration, and workforce development. Because participant interests varied across cohorts, workshop topics were adjusted over time to reflect identified learning needs. To support ongoing learning, workshop recordings were stored within Microsoft Teams and remained available to current and future cohorts.

Table 1.

Participant characteristics by cohort.

Table 1. Long description

Table 1 presents participant characteristics for three mentorship program cohorts totaling 133 participants. This table summarizes participant demographics and professional characteristics. Across cohorts, participants included 37 mentors (28%) and 96 mentees (72%). Most participants were clinical research coordinators (94%), female (88%), held a bachelor’s or master’s degree, were at the fundamental experience level (77%), and participated in clinical trials (81%). Participants represented diverse professional backgrounds and research activities.

Note: Cohort percentages were calculated using the total number of participants within each cohort (Cohort 1 = 51, Cohort 2 = 52, Cohort 3 = 30). Total percentages were calculated using all participants across cohorts (N = 133). Assignment of mentor and mentee roles was based on participant experience, availability, willingness to mentor, and prior mentoring experience, with mentees paired to experienced coordinators. Role experience levels were defined as Fundamental (<2 years in the current role), Skilled (>3 years of clinical research experience and >3 years in the current role), and Advanced (>6 years of clinical research experience and >6 years in the current role).

*Participants could select more than one response for race/ethnicity and research activity type; therefore, percentages for these variables may exceed 100%.

Digital platform

Microsoft Teams Classroom served as the program’s digital workspace for communication, group-based activities, and resource sharing. The Home page provided an easy-access dashboard to event calendars, a question-and-answer board, mentor and mentee checklists, contact information, reminders, and housed a Bookings schedule for additional protocol consultation services. Additional applications used throughout the platform included SharePoint, Planner, Whiteboard, Reflections, and Kudos to support program activities [Reference Lawson, Barros, Evans and Saleem11]. A clinical research library was created and organized by JTF domains [12] to share resources and support research navigation. In addition to the general communication pathways and Teams chat, each group had a private channel for group-specific use.

Evaluation phase

In the Evaluation Phase, formative and summative feedback were reviewed and used to improve cohort program operations, activities, workshops, and resources [Reference Branch14]. The Kirkpatrick Model measured program effectiveness at four levels: Reaction (Level 1), Learning (Level 2), Behavioral Change (Level 3), and Results (Level 4), evaluating participant experiences, learning outcomes, application, and program sustainability [Reference Kirkpatrick and Kirkpatrick22]. Engagement indicators provide insight into the participant’s program experience and perceived quality [Reference Quinton, Tidmarsh, Parry and Cumming23]. Previous studies indicated that professional recognition is an important motivator for TWD program engagement [Reference Carey, Dunn and Braxton3,Reference Lee-Chavarria, Loucks and Paranal7]. In response, Credly acceptance rates (digital badge and program completion certificate) and sharing rates (social media) were monitored as additional engagement indicators.

Data collection and analysis

Quantitative and qualitative feedback were collected throughout the program using Qualtrics and Microsoft Forms: T0 (registration and participant preference surveys); T1 (pre-program assessments); T1–T6 (workshop evaluations); T3 (formative evaluation); and T6 (post-program surveys). Kirkpatrick Level 1 (Reaction) measures included program satisfaction, perceived value, program recommendation, and interest in future program participation. Sense of community was preliminarily assessed using the Sense of Community Index 2.0 (SCI-2) [24] in Cohort 1 and supplemented with measures of networking, connection, and community engagement in subsequent cohorts. Kirkpatrick Level 2 (Learning) focused on participants’ self-reported KSC improvements [12,13]. For mentees, pre- and post-assessment surveys focused on JTF competency domains [Reference Jones, LIU, Hornung, Fritter and Neideker17], whereas mentor assessments focused on CIMER Entering Mentoring competencies [Reference Hyun, Rogers, House, Sorkness and Pfund19]. Kirkpatrick Level 3 (Behavior) examined participant behavior change and application of learning to CRP research workflows and mentoring practices [Reference Kirkpatrick and Kirkpatrick22,Reference Quinton, Tidmarsh, Parry and Cumming23]. Kirkpatrick Level 4 (Results) measured program completion and participant-to-mentor progression to evaluate program feasibility, sustainability, and organizational impact [Reference Kirkpatrick and Kirkpatrick22,Reference Quinton, Tidmarsh, Parry and Cumming23].