Becoming, Being and Building: A Qualitative Descriptive Study of the Experiences of Clinical Research Nurses

ABSTRACT

Aim

To explore the experience and practices of clinical research nurses in Victoria, Australia.

Design

Qualitative descriptive design with reflexive thematic analysis.

Methodology

Semi‐structured interviews were conducted with ten clinical research nurses between October and December 2023 in Victoria, Australia.

Results

Three phases (overarching themes) were generated: (1) Becoming a clinical research nurse, occurred by chance with a stressful and unsupportive transition period; (2) Being a clinical research nurse, was described as an ongoing development of confidence, specialised skills and knowledge; and (3) Building a clinical research nurse role, was described as challenging due to limited educational and career opportunities.

Conclusion

Clinical research nurses experienced a limited number of clear educational and career pathways that they could use to plan and grow in the nursing profession.

Implications for the Profession and/or Patient Care

Addressing support and career development needs may ease clinical research nurses' transition and improve career planning.

Impact

This study addresses a gap by highlighting the limited structured career pathways, formal mentorship and ongoing educational planning for clinical research nurses. Findings illustrate that clinical research nurses often begin unprepared, gradually develop confidence and skills, but continue to struggle with unclear career development plans. The findings can inform nursing leadership, educators and policymakers to better support clinical research nurses.

Reporting Method

The Consolidated Criteria for Reporting Qualitative Research Checklist (COREQ).

Patient or Public Contribution

No patient or public contribution.

What Does This Paper Contribute to the Wider Global Clinical Community?

• Identifies key gaps in mentorship and formal education for clinical research nurses.

• Supports recognition of clinical research nursing as a specialised role.

1. Introduction and Background

Research is an integral part of healthcare, enabling healthcare professionals to test the safety and efficacy of new treatments while contributing to innovation in medical research and better patient outcomes (Khan et al. 2016). Clinically based research, including studies conducted in hospitals with patients as participants, is guided by well‐designed protocols and ethical standards (Cetroni 2024). There is a vast range of different studies conducted in healthcare settings, ranging from clinical trials of new medicines or therapies, observational studies of how medical conditions track across populations or qualitative studies aimed to explore people's experiences of healthcare (Gibbs and Lowton 2012; Ness 2020). Traditionally, these studies are led by researchers or doctors (Bhatt 2010; Hastings et al. 2012; Stolley et al. 2000). However, in order to run effectively within a hospital setting, many studies are coordinated and overseen by specialist clinical research nurses (CRNs).

The role of the CRN was first established in nursing in 1910 by the clinical research institution at Rockefeller University Hospital in the United States (Ness 2020), and has since expanded across various healthcare settings, with CRNs now found working in a range of diverse settings and roles (Backman Lönn et al. 2022; Ness 2020). CRNs play an important role in clinical research, collaborating closely with principal investigators and other team members in the implementation of clinical trials (Alomari et al. 2023; Ness 2020). However, whilst the specialisation of clinical research nursing was formally recognised in the standards of practice by the American Nurses Association and the International Association of Clinical Research Nurses in 2016 (Hernon et al. 2020), challenges remain in defining the role and responsibilities of CRNs. Recent studies have shown that the scientific community is often unclear about how CRNs function within a research team (Backman Lönn et al. 2022; Gibbs and Lowton 2012; Hernon et al. 2020). This is due, in part, to the fact that CRN roles and responsibilities often vary based on employer, study type and even country (Bevans et al. 2011; Brinkman‐Denney 2013). The confusion over responsibilities is often compounded by a lack of consensus regarding the job title of CRNs. A wide range of job titles may be used to describe CRNs, including clinical research coordinator, trial coordinator and clinical research nurse (Lönn et al. 2022).

The confusion about the role and scope of CRNs is also evident within the speciality itself. For nurses aspiring to become CRNs, unclear educational and career pathways leave many nurses unsure of how to get started and unprepared for their roles (Gibbs and Lowton 2012; Hernon et al. 2020; Lönn et al. 2022). For example, although Australia recently released the updated standards for nursing practice, which recognised the CRN role (Australian College of Nursing 2022), specific educational pathways for Australian nurses to become CRNs and then specialise within their roles remain unestablished (Scott et al. 2013; Wilkes et al. 2012). This is similar in other Western countries, such as the United Kingdom, the United States and Sweden (Backman Lönn et al. 2022; Jones et al. 2022; Kunhunny and Salmon 2017). Although international reports highlight the growing recognition of the CRN as a distinct specialty within nursing (Alomari et al. 2023; Cetroni 2024), a lack of formal career pathways, significant variability in job responsibilities and titles and limited structured education programmes are likely to contribute to confusion and job dissatisfaction among CRNs (Fisher and Kalbaugh 2012; Hill et al. 2022; Lönn et al. 2022). In addition, the absence of a standardised role definition can make it difficult for CRNs to advocate for professional recognition and plan long‐term career development (Kunhunny and Salmon 2017). This uncertainty may also affect recruitment and retention, particularly when nurses feel unsupported and unclear about expectations and progression opportunities within the role (Hill et al. 2022; Tinkler et al. 2018).

Over the past two decades, the number of clinical trials conducted in Australia has increased, leading to an increased demand for nurses working as CRNs (Wilkes et al. 2012). Although Australia has recognised the CRN as an important workforce in nursing, releasing its standards for practice in 2022, the educational pathways to becoming CRNs and the career pathways for CRNs to grow remain unestablished (Australian College of Nursing 2022; Ness 2020; Wilkes et al. 2012). The exact number of healthcare organisations that currently employ CRNs also remains unclear. Although formal reports on the number of CRNs working in Australia are unknown, 2700 registered nurses and midwives in Australia self‐identified as researchers (both academic and clinical) in 2015, representing < 1% of the entire national nursing and midwifery workforce (Australian Institute of Health and Welfare 2016).

In the current literature, there is little description of the career progression pathway for registered nurses moving from bedside nursing into the speciality of clinical research nursing and become experts in their role, especially in an Australia context. Therefore, to better understand the experiences and roles of CRNs and how they move from novices to experts, the aim of this study was to explore the experiences and practices of clinical research nurses, focusing on their roles, responsibilities and experiences in managing clinical trials throughout their journey from junior to more experienced CRNs.

2. The Study

2.1. Aim

To explore the experiences and practices of Clinical Research Nurses in Victoria, Australia.

2.2. Research Question

The overarching research question was: What are CRNs' experiences of their role and responsibilities?

3. Methods

3.1. Design

This study used a descriptive qualitative approach, as outlined by Sandelowski (2000). This method allows researchers to stay close to the original meaning of the data and the way the participants discuss it, rather than apply an overly theoretical understanding of what is occurring, ensuring findings are useful in guiding future policy and practice (Sandelowski 2000). As this study aimed to explore the experiences and practices of CRNs through interviews and provide initial insights to guide future education and practice, qualitative description was deemed the most appropriate choice.

3.2. Study Setting and Recruitment

Clinical research nurses currently working in healthcare organisations in Victoria, Australia were recruited using a combination of purposive and snowball sampling. Purposive recruitment was undertaken through a presentation at the Victorian Affiliation of Research Nurses Incorporated (VARN) annual meeting attended by 60 CRNs in October 2023. Study information was also distributed to all 98 CRN members via the VARN mailing list. In addition, all nurses who took part in the study were asked to pass our contact details to other interested colleagues, as part of snowball sampling. Inclusion criteria for the study are outlined in Table 1.

TABLE 1.

Inclusion criteria.

Registered nurses in a clinical research capacity in Victoria, Australia

Working in clinical research for more than 6 months

Works more than 3 days every week

A total of ten CRNs participated in this study. Four research nurses were purposively recruited following informal discussion at the VARN meeting. Additionally, three CRNs who missed the meeting but received study information via email expressed interest and agreed to participate. A further three participants were recruited via the snowball sampling recruitment methods through word of mouth from VARN members.

3.3. Data Collection

Data were collected through semi‐structured, audio‐recorded individual interviews conducted in English via Zoom, which lasted between 50 and 80 min. An interview guide (Figure 1) was developed based on a review of the literature and the research team's experience of the topic and was piloted before use with two CRNs who did not participate in the study. The two pilot interviews were recorded and reviewed by the research team to ensure that key areas of the CRN experience were covered and that the interview process was clear and logical. As a result, two questions were removed, one was added and several were reworded and reordered. As is common in qualitative studies, additional prompts were also added throughout the interview process in response to participant responses.

FIGURE 1.

Interview guide.

Each interview was conducted by the first author, a research student with a background in clinical research nursing. In addition, an experienced female qualitative researcher [AEB] was also present in each interview to support the research student as needed and to facilitate ongoing training and debriefing. During and after each interview, reflective notes were taken by the first author to identify follow‐up questions and developing ideas. These were discussed and reviewed with the research team to guide subsequent interviews and to keep an audit trail. To minimise any potential coercion, eligible CRNs with a pre‐existing relationship with the first author were invited to contact the other research team members if interested in participating in the study. They were also given the option to be interviewed by others in the team to ensure comfort and confidentiality. One such participant chose this option but was happy for the first author to analyse the data.

As suggested by Braun and Clarke, the concept of information power was used in this study to decide the point at which to stop collecting further data (Braun and Clarke 2022; Malterud et al. 2016). Given the specific aim of the study, the richness of the data generated in the interviews and the highly specific population under study, sufficient data and information power to address the study aims was identified by interview nine as information was beginning to be repetitive with no new themes, content or topics emerging in data. This was the case also in interview ten after which further data collection was discontinued.

3.4. Data Analysis

All interviews were recorded using Zoom's cloud‐based audio recordings feature and were initially transcribed automatically, then manually checked for accuracy by the first author. All data were de‐identified using codes. Reflexive thematic analysis (RTA) was then used for data analysis, following the six steps outlined by Braun and Clarke (2022): familiarisation with the dataset; coding; generating initial themes; developing and reviewing themes; refining, defining and naming themes; and writing up. The analytic process was undertaken primarily by the first author and reviewed regularly by the additional authors to allow the research team to reflect on their own assumptions, categorise data and report on what was occurring.

To begin the familiarisation process, each transcript was read multiple times to ensure deep familiarity with the data. As part of the process, a summary was also written for each interview, with initial analytic ideas noted. From there, coding was undertaken using an inductive coding approach to fully explore the perceptions and experiences of CRNs in relation to their role. To facilitate coding, all transcriptions were imported into NVivo and analysed line by line to generate initial codes. To enhance the credibility of the data analysis and minimise potential bias, regular team meetings were held throughout the entire data analysis phase. These meetings involved reviewing coding, interpreting data and discussing emerging themes. The frequency and recurrence of codes were examined to identify those most prominent in the data, consistent with Braun and Clarke (2022) suggestion that coding categories are generated from the data and confirmed through the pattern. Codes were then labelled and organised into preliminary groups in a process of generating initial themes. To continue developing, reviewing and refining themes, mind maps and diagrams were created to visualise connections within the data. These groups were reviewed across transcripts to explore similarities and differences, helping to refine, name and organise them into sub‐themes and overarching themes, as shown in Table 2. Finally, in the write up step, we wrote each theme together to tell the overarching story of the participants' experiences.

TABLE 2.

An example to show the process of grouping data into an overarching phase.

Data	Code	Sub‐theme	Theme	Overarching phase
“She knows me, and she came me one day. She came, ‘Participant 1, do you want to try a research nurse?’”	Word of mouth	Taking a chance by making a change	Understanding research in nursing	Becoming
“I think I needed to have that changed so I just jumped in and did it. I don't, to be honest, I can't remember too much back that far, but it was the change that I needed to try something else”	Just did it	Limited prior experience and expectations
“I was thrown under the bus again in terms of knowing what I was, I mean, you know what trials are like pharma trials are like. It's a whole new language, basically. And I also had to revisit the whole language of diabetes and endocrinology and learn lots there”	Whole new language	A steep learning curve	Facing transition challenges
“And that admin type of roles you wouldn't normally find yourself doing if you worked on a ward, or you know, in an area such as day oncology. So it took me a little while to get used to not always doing clinical roles at all times in my shift”	Admin type of role	Burdensome administrative tasks

3.5. Ethical Considerations

This study was approved by the La Trobe University Human Research Ethics Committee, Project Number HEC23337. All participants were provided with a written copy of the information sheet, which was verbally discussed prior to each interview. Written consent to take part in the study was provided by each participant. In addition, as the primary author was a research nurse and may have been known to some participants, all participants were given the option of being interviewed by another member of the research team. One participant took up this offer, though was happy for the primary author to access and analyse their data.

3.6. Rigour and Reflexivity

To enhance transparency and trustworthiness, this study is reported in accordance with the consolidated criteria for reporting qualitative research (COREQ) guidelines (Tong et al. 2007).

The authors are all nurses. The first author is a female research student with experience working as a clinical research nurse. During her clinical work, the first author witnessed the challenges faced by CRNs across different hospitals and also noticed the lack of formal role description or education available to guide CRNs through their careers. During formal postgraduate studies, these experiences inspired the first author to further explore the experiences of CRNs across their careers, in the hope of contributing to more formalised transition and support pathways for new CRNs. The second (male) and third (female) authors are both experienced qualitative researchers holding senior academic positions in nursing research and education and provided supervision and mentorship to the first author throughout her degree.

Lincoln and Guba's (1985) framework was followed to ensure the study's trustworthiness. To enhance the credibility of the study, the research team maintained various logs and records, such as a screening log, participant log and interview records to rigorously verify participants' eligibility and background as well as data content in relation to interpretations. The analyses were performed by the first author in repeated meetings with the research team to discuss the coding and themes until agreement was reached. Additionally, a summary of the findings was presented to the VARN community for feedback and reflection in 2024 by the first author to further increase credibility. Transferability was supported by the diversity of the participants, including different age groups and research departments and by providing detailed information about the participant and study settings as well as providing sufficient descriptive data for readers to assess the transferability to other settings. To address dependability, detailed audit trails were established and maintained, including meeting minutes, interview summaries and reflective notes documenting methodological and analytical decisions. Further, confirmability was ensured through regular fortnightly meetings to discuss developing findings and the development of detailed plans and minutes, with all aspects of the research process being reviewed and documented collaboratively to facilitate confirmability.

We were also guided by Braun and Clarke (2022) in adopting processes to enhance rigour. These included maintaining audit trails, gaining insight through regular research team communication and presenting findings formally to VARN for feedback. In addition, considerable time was taken to allow analytic insights to fully develop, ensure appropriate immersion in the data and carefully refine all theme names through multiple iterations.

4. Findings

Ten clinical research nurses (eight females and two males) took part in this study. The participants ranged in age from their mid‐20s to mid‐50s and worked across a variety of specialities in seven public hospitals in Melbourne, including endocrinology, cardiac care, neurology, sexual health and wellbeing, haematology and immunology. Three held Master's degrees, and seven had Bachelor's degrees. There were two participants of Chinese descent, one of Indian descent, and the rest were of European descent. Nine participants worked full‐time, and one worked 4 days a week. Their nursing experience varied from three to 28 years, and their CRN work experience ranged from 7 months to 22 years. The summary of participants demographic data is presented in Table 3.

TABLE 3.

Summary of participant demographics.

Participants	Nursing experiences (years)	CRN experiences
Participant 1	23	4 years
Participant 2	7	7 months
Participant 3	10	2 years
Participant 4	23	6 years
Participant 5	27	22 years
Participant 6	15	8 years
Participant 7	18	15 years
Participant 8	12	1 year
Participant 9	37	8 years
Participant 10	20	7 years

Overall, three overarching phases of the CRN journey were developed from the data, representing three distinct stages of a CRNs professional journey: becoming, being and building (Figure 2). Findings highlight the CRN's perceptions of their roles, responsibilities, challenges and experiences at each stage of their professional growth. In general, participants experienced the phases as sequential within their current role. However, when they moved to a new role in another department or specialty, even if they were experts in their previous role, they felt they had moved back to the start of the process through the stages again. Similarly, moving between trials often required them to re‐learn and re‐establish their process.

FIGURE 2.

Overview of key findings.

5. Becoming

The first phase of the CRNs journey focused on becoming a CRN. In this phase, CRNs focused on their initial entry into the role, with two main themes developed: ‘understanding research in nursing’ and ‘facing transition challenges’.

5.1. Understand Research in Nursing

For the participants, the process of becoming CRNs was challenging and often occurred by chance, with many participants reporting that they felt unprepared and unsupported to move into the world of clinical research. Two key sub‐themes were generated: taking a chance by making a change and limited prior experience and expectations.

5.1.1. Taking a Chance by Making a Change

For many of the participants in this study, their CRN job opportunities came through ‘word of mouth’ (participant 7) or being directly ‘asked to apply for the research nurse position’ (participant 6), rather than seeing an advertisement. They decided to take a chance on the new role for several reasons. Most commonly, participants were motivated towards the CRN role by ‘the better hours and that work life balance’ (participant 7), as it meant no ‘shift work’ (participant 6) or ‘night shift anymore’ (participant 8). Despite not actively seeking out the role, they ‘just jumped in’ (participant 7) and began trying to understand what research in nursing could look like.

5.1.2. Limited Prior Experience and Expectations

Many participants in this study also described a limited understanding of the CRN role prior to starting. Seven participants had ‘never been in any sort kind of a trial’ (participant 2) and had ‘no exposure to research in my training at all’ (participant 1). Only three participants had prior research exposure, but it was ‘very haphazard’ (participant 5), mainly assisting with tasks like ‘help[ing] with their patients having treatment’ (participant 3), though this was commonly done ‘without a protocol’ (participant 5). Due to their lack of prior research exposure, all participants in this study ‘didn't really have expectations at all’ (participant 9) about the role and were unaware of the upcoming challenges of transitioning into the CRN role.

5.2. Facing Transition Challenges

By taking a chance and making a change, CRNs in this study came to understand ‘that research was a component to nursing’ (participant 3), offering a unique career path to begin their journey as CRNs. However, they encountered several significant challenges as they transitioned into their CRN roles. These are described across three sub‐themes: a steep learning curve, burdensome administrative tasks and a baptism of fire.

5.2.1. A Steep Learning Curve

As CRNs entered their new role, they found themselves in a constant cycle of learning and relearning. Many participants described feeling as though research was a ‘whole new language’ (participant 9) with ‘a big learning curve’ (participant 10). Their general nursing background provided only ‘basic nursing knowledge, but nothing too in depth’ (participant 8) related to research, which was insufficient for their new CRN roles. The participants felt that needing to ‘keep learning every protocol’ (participant 5) was ‘the hardest part’ (participant 2), especially with several studies active at the same time. The CRNs also noted that ‘getting my head around the ethics and how to manage that’ (participant 8) was the most frustrating aspect of learning their new non‐clinical responsibilities, as they ‘haven't had any experience before’ (participant 10).

5.2.2. Burdensome Administrative Tasks

For the participants, the CRN role entailed a much larger portion of administrative or non‐clinical responsibilities than they had expected; for some, this was up to ‘80% of the time is with the admin’ (participant 5). These non‐clinical activities included ‘data collection, [data] entry that's constant too…print off all the results that keep getting emailed through’ (participant 9), which often meant they had very little patient contact. Managing data registries also made some participants feel ‘bound to a laptop’ (participant 4). However, despite the challenges, the CRNs recognised that their administrative‐focused role was ‘a different type of busy’ compared to ward nursing. As noted by participant 3: ‘the load of administrative duties can be just as big as the busy people clinical duties’ (participant 3), which was something many CRNs had not fully appreciated at the start.

5.2.3. A Baptism of Fire

Participants identified that, almost exclusively, their introduction to the role was ‘learned on the job’ (participant 9), which was a key component of facing transition challenges as participants learnt to become a CRN. Most participants felt there was ‘no professional training’ (participant 1) and no ‘mentor … maybe not even preceptor’ (participant 7) when they first started in their role, so they had to ‘figure it out on my own’ (participant 8). Many CRNs described informally shadowing senior colleagues, ‘observing and [seeing] as much as we possibly can’ (participant 2) and self‐directed external ‘educational resources’ (participant 8) to navigate their becoming phase in the journey as CRNs. For some, this was compounded by ‘a very quick handover of what needs to be done’ (participant 7) from their predecessors, making this already difficult transition even more challenging. Several CRNs stated that they had no idea what they were doing when they started their roles, describing the experience as ‘a baptism of fire’ (participant 4) or being ‘chucked in the deep end’ (participant 7). As participant 4 recalled: ‘I was just absolutely flying by the seat of my pants, and then what? I wasn't sure, particularly around the governance stuff’.

However, this experience of being ‘chucked in the deep end’ was not universal. In contrast to others, three participants found ‘the transition was smooth’, commonly due to ‘a small unit, a small number of projects, and not a huge workload, so … I had time to learn’ (participant 1). Support from external departments, such as the ‘ethics team, finance manager’ (participant 6), also made non‐clinical responsibilities like ethics submission ‘much easier’ (participant 5), which helped to reduce the transition into the CRN role.

6. Being

Once CRNs had transitioned into their new CRN role, they began the process of being a CRN. Primarily, this phase focused on the CRNs’ developmental journey from being a junior CRN to being an experienced CRN, with three main themes: ‘utilising transferable skills’, ‘consolidating coordination expertise’ and ‘finding role satisfaction and diversity’.

6.1. Utilising Transferable Skills

All participants in this study identified that ‘being a [general ward] nurse for a couple of years and having more experience, could help you do the [CRN] role a little more effectively’ (participant 3). Their bedside nursing skills, including ‘good communication skills’ (participant 6) and ‘being organised and multitasking’ (participant 10) were felt to be an asset ‘that carries over into research’ (participant 4). For example, years of bedside nursing enabled CRNs to effectively ‘answer questions’, break ‘concepts down’ (participant 4) and ‘to word questions differently if the person doesn't understand what I'm asking’ (participant 8), ensuring complex research studies were understandable to participants. In addition, strong time management skills developed through juggling multiple priorities on the ward enabled CRNs to prioritise key research tasks, even if unexpected. For example, participant 4 noted ‘when the STEMI patient comes in, and so that experience that I've got, I can then transfer into understanding the stress of the patient at that time, undertaking the need for speed’. These skills helped new CRNs gradually build confidence in communicating with the research team and in prioritising the different requirements of a research study, which meant they were able to feel more confident in their skills and abilities. As CRNs developed in confidence and competence, they became better at ‘word[ing] questions differently if the [patient] doesn’t understand’ (participant 8) and ‘navigat[ing] issues or problems or hurdles a little bit more efficiently and independently’ (participant 3).

6.2. Consolidating Coordination Expertise

In addition, participants in this study also felt the CRN role expanded their core nursing skills beyond traditional patient care and towards developing skills focused on coordinating research studies with ‘internal [research team member] and … a lot of external collaborators’ (participant 10). Initially, this coordination involved arranging simple patient appointments, such as ‘[diagnostic] imaging’ (participant 3) tests, ‘bone marrows [bone marrow aspirate testing]’ (participant 6) and ‘extra eye appointments or radiological appointments’ (participant 9). However, as their coordination expertise grew, CRNs built ‘good relationships’ (participant 1) with other departments, working with many ‘different laboratories’ (participant 10) and ‘dealing with sponsors … and [trial] monitors’ (participant 9) to ensure the success of a trial. With increased experience in ‘opening trials and getting that experience’ (participant 3), CRNs developed a deeper ‘understanding [of] the responsibilities’ (participant 5), became ‘less anxious’ (participant 8) in their CRN roles and gained confidence in making ‘the right call with regards to ensuring that the visit happens well’ (participant 5). As noted by participant 9, these were skills that ‘you can't know at the start’, but instead developed with time and experience. Generally, most participants felt that it took between ‘probably three to six months’ (participant 8) to ‘a good year’ (participant 3) to ‘have the confidence’ (participant 3) in their role and their coordination expertise.

6.3. Finding Role Satisfaction and Diversity

Nine participants in this study reported they ‘really enjoy’ (participant 9) working as a CRN for a number of reasons. For many participants, ‘the greatest benefit [of the CRN role] is having a broader impact on the larger community’ which ‘can be global as well’ (participant 10). This sense of having an impact on the broader community was an important part of the CRN journey, feeling that their contributions improved ‘standard of care for some treatments for some diseases’ (participant 6). As expressed by participant 3, ‘I take a lot of pride in my work … in research, and innovation, and new treatments that are going to change the trajectory of nursing in the medical profession’. In addition, CRNs enjoyed building ‘patient rapport’ (participant 7) through clinical trials, describing interactions as ‘really pleasant’ (participant 8) and noting that trial patients ‘want to be there’ (participant 7). This positive experience made the role ‘a lot less traumatic than the ward work’ (participant 9). Over time, CRNs felt their ability to ‘think[ing] and engag[ing] with patients’ (participant 9) improved, allowing them to provide ‘one‐on‐one supportive care’ (participant 3) and feel like ‘really good friends’ (participant 7) with their patients.

However, role satisfaction could often be dampened by challenges related to the diversity of the CRN role. For example, a lack of consensus on job titles and responsibilities made it difficult for CRNs to know where and how they fit into the research team, both within and between hospitals and wards. For participants, the use of multiple but poorly defined job titles such as ‘research coordinator … trial coordinator or nurse trial coordinator, … [or] study coordinator’ (participant 9) or even ‘clinical project coordinator and research nurse’ (participant 8) created confusion for the CRNs about whether these titles all described the same role or whether they required different skillsets and responsibilities.

The CRNs in this study also noticed significant differences in their actual responsibilities across different departments. This often exacerbated uncertainty regarding the requirements of different roles and the transferability of skills between hospitals. For example, some CRNs were responsible for ‘recruiting people from the community’ (participant 8), ‘pathologies spinning [processing blood samples]’ (participant 2), ‘capturing AEs [adverse events]’ (participant 6) and ‘consent[ing] patients’ (participant 10), whilst others engaged in more non‐clinical duties, such as ‘creating source documents’ (participant 7), ‘deal[ing] with the ethics committees and RGO [research governance offices]’ (participant 8), ‘doing all the invoices for all the trials’ (participant 9), ‘developed the protocols and documentation’ and supporting ‘PhD [Doctor of Philosophy] students’ (participant 10). The CRNs in this study found that this variation in roles and responsibilities under similar job titles created confusion and ambiguity, which made it difficult for CRNs to move between roles, between departments and hospitals. As noted by participant 5, ‘It would be better to have a defined role. I think it would be better to just have it defined properly’.

7. Building

Finally, as the nurses in this study described becoming more experienced, they looked towards building their future career as expert CRNs. However, many described struggles in achieving this, often related to ‘job insecurity’ and ‘limited educational and career pathways’.

7.1. Struggling With Job Insecurity

Almost exclusively, CRNs in this study felt they were struggling with job insecurity due to short‐term contracts, which left them in constant uncertainty regarding their future career advancement. Participants frequently mentioned that they ‘are self‐funded’ (participant 5), meaning they were responsible for generating the funds from incoming research studies to cover their own salaries. As a result, nine of the 10 CRNs in this study had to renew their contracts ‘either yearly or two years depending on funding’ (participant 10). This self‐funding model for research nursing created stress and anxiety for CRNs, as there was uncertainty about the number of research projects the team could undertake and the number of patients the CRNs could recruit, which ultimately limited funding for CRN positions. As participant 7 pointed out, it was their responsibility ‘to make sure you got patients [recruited patients in trials], to be able to pay the bills [staff salaries] and pay your manager’. This led to a ‘negative [feeling] about being a new research nursing’ because ‘job security is not really there’ (participant 7).

This in turn significantly restricted how CRNs could plan for their future career advancement and affected their professional motivation. Some participants described difficult situations where, by the time new CRNs settled in the role, they only had a short period before their contracts ended; this sometimes led them to consider whether ‘to leave because we’ve had a year contract, and then they [new CRNs] wanted to do something else’ because they wanted more job security, as stated by participant 9. This cycle was problematic, as it often resulted in the nursing research team starting the recruitment process all over again, which posed new challenges: ‘it's quite difficult to recruit for research nurses because it is so specialised’ (participant 10).

7.2. Limited Educational and Career Pathways

Many CRNs in this study also desired an opportunity to continue to build and develop their career, but found there was ‘no pathway; there's no postgraduate course available’ to guide them to advance their careers as ‘a research nurse’ (participant 1). This was often discussed in contrast to the clearly defined and advertised pathways to other clinical nursing specialisations which had clearly defined postgraduate courses. In contrast to specialties like operating room nursing or emergency nursing, participants identified that they were ‘not aware of really any other particular ways [to specialise as a clinical research nurse] other than just getting a job’ (participant 4), which made it difficult to grow from a graduate nursing career to a clinical research nursing career. This limited availability of clear specialisation pathways and the observation that ‘I still haven't even really seen much other research activity in the hospital’ (participant 3) added to the uncertainty of how participants felt about building their careers. Some participants in this study expressed a desire that they ‘would quite like to do some more tertiary education’ (participant 8) but were not ‘familiar with the possible areas of progression’ (participant 3) or how to take ‘the next step… with my professional development’ (participant 1). Even some experienced CRNs felt more transitional support was required when moving between their specialities and hospitals, as they often felt like ‘novices again’ (participant 7). This was experienced as being ‘placed back at the starting line’ (participant 9) because they had to ‘learn new [study] protocols’ (participant 4) and adjust to different ethical requirements and research study processes.

8. Discussion

This study explored the experiences of clinical research nurses working in Victoria, Australia. Findings show that CRNs commonly transition through three key phases as they progress from bedside nurse to experienced clinical research nurse. For most nurses, becoming a CRN occurred by chance and involved a stressful transition. Being a CRN involved developing specialised skills for effective research trial coordination, with growing expertise boosting confidence in managing clinical trials and patient care. Finally, building the CRN role was challenging due to limited educational and career opportunities, leaving CRNs uncertain about their future growth.

This study contributes to the understanding of the challenges and experiences faced by CRNs across each phase from an Australian perspective. It highlights CRNs' difficult transitions into the roles, their struggles with inconsistent roles and responsibilities and limited career advancement opportunities. These findings suggest the need for clear role definitions (e.g., definitions of CRN versus clinical project coordinator), structured mentorship and formalised career pathways to support this vital workforce and promote job satisfaction nationally and internationally.

Our findings indicate that for many clinical research nurses, entry into the specialty occurs by chance and with little prior experience of or exposure to clinical research as part of their undergraduate education or their clinical work. This finding may in part be due to the relative recency of any formal recognition of clinical research nursing as a nursing speciality in its own right, especially within the Australian context (Australian College of Nursing 2022). However, Australia is not unique in this respect. Whilst the CRN role has existed for decades, it was only officially recognised as a nursing speciality by the American Nursing Association in 2016, with similarly recent recognition noted in countries such as the United States, the United Kingdom and Ireland (Hastings et al. 2012; Jones et al. 2022). In addition, research skills are often taught separately from clinical practice skills in undergraduate nursing education, such that many nursing students and qualified nurses may not clearly see how research connects to their day‐to‐day work or view it as a viable career pathway (Drury et al. 2024; Horntvedt et al. 2018). Moving forward, research and nursing roles in research need to be better integrated into both undergraduate and postgraduate nursing education. In particular, student and graduate nurses could be offered more opportunities to engage in direct clinical experience of undertaking or supporting research studies alongside clinical research nurses and other nursing research leaders.

In addition, our findings highlight significant challenges that CRNs face during their transition into their roles and the perceived relative lack of support, mentorship and formal training that is available to them. Our findings suggest that even experienced CRNs need transitional support when moving hospitals, departments or specialities. Prior clinical research experience does not guarantee a seamless transition and without adequate support, experienced nurses may still face challenges when entering or moving between CRN roles. Similarly to findings by Lönn et al. (2022) and Tinkler et al. (2018), participants in this study described a steep learning curve and feeling like novices despite years of bedside nursing experience. In addition, participants in our study noted that the absence of formal training and structured mentorship further intensified these challenges during the becoming phase of their CRN journey. Similar challenges for formalised CRN training or mentorship have been reported in other studies, both in Australia (Rickard et al. 2011; Scott et al. 2013) and globally (Backman Lönn et al. 2022; Jones et al. 2022; Kunhunny and Salmon 2017; Lönn et al. 2022). Unfortunately, this finding is not new, with a lack of formalised training for CRNs first reported in Australia in 2011 (Rickard et al. 2011), suggesting that limited progress has been made over the last decade. The reasons for this are likely multifactorial, including a limited CRN workforce, the relative recency of formal recognition for the CRN role and a greater focus on training undergraduate student nurses to address ward nursing shortages, rather than a focus on nurse research training. Moving forward, clear and accessible educational pathways, including partnerships between healthcare institutions and universities to design CRN‐specific programmes, are needed to address educational and career pathway gaps. For nurses already in the CRN role, more work is needed to support transition and career development. Hospitals could also consider creating formal mentorship structures for novice CRNs to learn from experienced mentors, facilitating knowledge transfer and professional development.

Our findings also showed that although CRNs rely on a balance of both new and old nursing skills to carry out their CRN roles, they often face challenges related to both inconsistencies in the role nomenclature and in the different expectations of them across different hospital and ward settings. For example, some participants in our study were referred to as research nurses, while other were called trial coordinators. Whilst some CRNs used many clinical nursing skills in their roles, others were required to undertake more administrative tasks. This variation made it difficult to define the role consistently or assess the transferability of skills across hospitals. This is similar to findings from other studies (Backman Lönn et al. 2022; Bevans et al. 2011; Lönn et al. 2022; Scott et al. 2013), which have shown that variability in job titles and role ambiguity for CRNs contribute to dissatisfaction and career uncertainty. Our study extends this existing literature, highlighting that these inconsistencies remain unresolved over a decade later, affecting job mobility and access to role specific training for CRNs. Moving forward, the development of a set of national or international standards for clinical research nursing practice would help to minimise this inconsistency, reducing confusion, supporting consistent role expectations and enhancing professional recognition.

Finally, as the CRNs in this study continued building their careers, they struggled with job insecurity due to their annualised contracts and found it difficult to advance further because of limited educational and career pathways within the postgraduate education space. This limited postgraduate specialisation in clinical research nursing appears to be unique to Australia (Wilkes et al. 2012). Other countries, such as the United Kingdom and the United States, offer Master's degrees or postgraduate certificates for nurses in clinical research to enhance the skills and knowledge needed to deliver and integrate research into clinical practice (King's College London 2025; The Ohio State University 2025). In contrast, although Australia offers courses and degrees for independent nurse researchers (e.g., Master of Nursing Research or Doctor of Philosophy programmes), they do not appear suitable for specialisation in clinical research nursing, where the focus is on trial management and patient care. Out study extends the work of Wilkes et al. (2012) by highlighting that, even though CRN was officially recognised as a speciality in 2022, the lack of accessible postgraduate courses continues to have significant impacts on CRN career development and progression as a specialty. Moving forward, enhancing the profile and visibility of CRNs as a viable career pathway requires clear and accessible educational strategies and partnerships between hospitals and universities. Ideally, this would begin at an undergraduate level and continue through to Master's or PhD level, increasing awareness of clinical research nursing as a legitimate nursing role and supporting them in building their research career.

8.1. Strengths and Limitations of the Study

The strengths of this study lie in the rigorous adherence to a well‐established methodology, and to the inclusion of a diverse group of male and female nurses of various ages, experiences and cultural backgrounds, offering a broad perspective on CRNs in many specialties. In addition, trustworthiness of the data and findings were ensured through the conduct of pilot interviews to confirm question clarity and refining the interview guide and maintaining an audit trail to document key methodological and analytic decisions. However, there are also some limitations. Primarily, our sample size was small, which may have limited saturation of the findings. All participants were members of a key clinical research nurse professional body in Melbourne, Australia, who volunteered because they were interested in the topic. They may have slightly different perspectives and experiences than other CRNs, particularly non‐VARN members, which may limit transferability of findings to non‐members or clinical research nurses working in other states and other countries. Additionally, as a CRN, the first author recognised the possibility of making assumptions based on personal experiences during the data analysis process. To minimise the potential bias, the research team were carefully guided by the data and engaged in ongoing reflexive discussions to minimise the impacts of our own preconceived ideas and experiences.

9. Conclusion

This is the first study in Victoria exploring CRN's experiences and practices across their career trajectory, demonstrating the transitions they encounter as they move from novice to experienced CRN. It highlights significant educational and career gaps, limited formal mentorship support and inconsistent job titles and responsibilities for CRNs. These findings reflect existing knowledge and shed further light into the complexities of the CRN role and journey, offering valuable insights for future practice, research and theory development. Given that the CRN development journey comprises different phases with different challenges, further research and support may be warranted. Moving forward, identification of hospital or state‐based sources of funding for CRNs, similar to the established funding structures available for ward nurses, is important to support career stability and progression. These dedicated funding can enable the development of more formalised mentorship and role induction pathways, while the establishment of structured university curricula, including training in research ethics, budget management and related processes may help to smooth transition pathways and strengthen the professionalisation of the CRN role.

Funding

The authors have nothing to report.

Disclosure

The authors affirm that the method of reflexive thematic analysis used in the data analyses is suitably applied to the study design and context. This is a qualitative study with no statistical analysis. The authors affirm responsibility for ensuring that the qualitative methods used are appropriate and correctly applied within the study design and context.

Ethics Statement

This study does not involve the use of genetic resources or biodiversity related fieldwork. Therefore, the Nagoya Protocol does not apply. Ethics approval was obtained from the La Trobe Human Research Ethics Committee prior to the commencement of the research (project Number HEC23337).

Consent

Participant information and consent forms were obtained from all participants prior to their involvement in the study.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

All full transcripts and raw data were de‐identified prior to analysis, and only the study team had access to the data. The de‐identified data have been securely stored in accordance with institutional data management and ethical policies. Due to the sensitive and confidential nature of qualitative interviews, full transcripts and raw data are not publicly available.