To the best of our knowledge, this is the first broad description of ICU clinical research personnel in Europe, from a country strongly involved in ICM academic research. Although our observations do not necessarily extend beyond France or to other medical specialties, they identify issues and hypotheses that could be relevant to broader fields.

The most typical profile of the clinical research personnel surveyed was that of a middle-aged woman, a Bachelor/Master graduate working full-time or almost full-time as a CRA or CRT in a university hospital, whose activity was fairly equally shared between the two functions. Training in clinical research had been done before and after hiring and completed by an average professional experience of 10 years. This profile is very similar to that of 98 research coordinators recently surveyed in Australasian ICUs [14]. The high female rate reflects the current sex ratio observed in healthcare professionals [15] and is probably helped by a favourable work-life balance [16]. The age distribution reflects a hiring wave that started about 25 years ago, which along with educational level and job functions is in line with French government policies since the creation in 1992 of clinical research offices in public hospitals, accompanied by increased dedicated funding [2, 5, 17].

To comply with GCP, the French Ministry of Health published in 2021 an index of jobs in the public hospital service, including clinical research [6]. In the index, the main jobs were clearly defined as: (i) launching research protocols and monitoring their quality on behalf of the sponsor (for a CRA); (ii) managing the logistics of research protocols and data collection under the responsibility of investigators (for a CRT); and (iii) managing a set of research projects with regard to their legal, financial, logistical, administrative, organisational, and human aspects (for a CRPM). The required educational level is practically the same for CRAs and CRTs, either a paramedical or other scientific Bachelor diploma, or a specific CRA/CRT university diploma, for which the training frame is less standardised. In practice, a nurse (Bachelor level) could be hired as a CRA/CRT, and about one-fifth of our sample actually had this qualification. This is a low rate compared to that in countries like Australia, New Zealand, UK, and USA [18,19,20,21]. Policy in French hospitals over the last 30 years has been to restrict nurses to care; education in clinical research has been included in the training syllabus of French anaesthetist nurses since 2014 only.

When our participants were asked to define the relationship between the jobs of CRA, CRT, and CRPM, and a list of predefined tasks—which were actually all supposed to fit to the job profile, significant rates of disagreement were observed for certain tasks. Personnel should, of course, be aware of all the tasks related to their jobs, but their differing perception of what they involve could have been due to the very recent publication of the list of tasks [6], and hence a limited awareness of their content. For example, ICU CRTs do not generally have to manage pre-analytical treatment of samples, which is usually done by the hospital laboratory resources. The 30-to-40% rate of inappropriate responses regarding the tasks of CRPMs may have been due to the fact that few of the responders were employed in such a position. Of note, the required educational level to be recruited as a CRPM is higher than for CRAs and CRTs, and most CRPMs are former CRAs/CRTs who have been upgraded after years of experience, as posts for CRPMs have only recently been created. As a result, we lack data on the number of CRPMs in French university public hospitals, but as they are more often located in dedicated offices than embedded in ICUs, this could influence several aspects of their job perception.

Most of the responders had the dual function of CRT and CRA and so had to manage studies sponsored by their own institution (mostly single-centre) and studies with external sponsorship (mostly multicentre). This dual function satisfies the principles of independence (from the sponsor for the CRT, and from the investigators for the CRA), provided one individual does not combine both functions in the same study. Although some institutions are reluctant to allow such multivalence, the current survey showed that it was rather attractive to the personnel, who had a positive perception of it, expressed high satisfaction with the organisation of their personal work, and cited autonomy as the most appreciated positive aspect of the job. The respondents also appreciated the variety in the type of studies they had to work on in terms of setting or sponsoring, and sharing activity with ICUs and other hospital units. This last situation was however specific to general hospitals where one specialty unit is not active enough to involve full-time personnel. Finally, taking part in unit staff meetings was positively perceived and should be encouraged in the ICUs where it is not yet common practice. In this regard, heads of department could act as useful motivators.

Studying job satisfaction, dissatisfaction, and stress can provide suggestions to help retain a specialised workforce such as ICU research personnel. The most cited negative aspects of the job (lack of time, administrative procedures, and paperwork) are probably common to any service job, and therefore hard to act on. However, as already reported in the literature, most attention should be given to how institutions manage careers [19]. Indeed, job satisfaction was average, and the institutional disregard of the needs of CRAs/CRTs and poor recognition of the job within the institution were often cited as sources of stress, and dissatisfaction with career management strongly correlated with job stress.

Some studies performed outside Europe have addressed these issues in research personnel. Two surveys conducted in 2004 and 2009 among 49 research coordinators (RCs) working in Australasian ICUs highlighted the value of autonomy, respect, and intellectual stimulation in the job, while isolation, under-recognition, workload, and under-remuneration were negatively perceived [18, 19]. Of note, we did not address the question of incentive bonuses as they do not really exist in the French public health system. Other teams have also studied the relationships between job satisfaction and personal psychological issues. A nationwide survey conducted in 2005 among 252 RCs in the USA showed that job dissatisfaction was a strong predictor of burnout, while satisfaction was moderately correlated with personal accomplishment [22]. A survey conducted in 2020 among 66 RCs working in Canadian ICUs identified unrealistic workload and weekend/holiday screening as strong stressors, while a positive work environment had the opposite effects [23]. Of note, RCs in the above-mentioned countries have a greater workload than personnel in France, especially on weekends. A study conducted in 2020 among 438 CRAs from 26 major cities across China showed that 82% manifested signs of occupational burnout, of whom half had moderate burnout. The rate of burnout was favoured by mode of working and workload, support provided by the hospital, and the likelihood of receiving a promotion [24]. However, these results could have been different in a period less stressful than that of the COVID pandemic. A study conducted in 2021 among 98 Australasian ICU RCs showed better psychological outcomes, with depression, anxiety, and stress scores within the normal range, and 21 to 27% of the respondents defined as positive to one of these three diagnoses [14]. Conversely, while overall job satisfaction was quite good and close to that in our survey (mean score of 3.5/5), 44% of the respondents exhibited an early symptom of burnout. Unfortunately, we did not assess burnout, but the Maslach Burnout Inventory used in the last two studies above was very sensitive and our observations are consistent with the rest of their results.

Dissatisfaction with training is also correlated with job stress, albeit to a lesser degree, but cannot be neglected because it is closely related to the demand for quality, as stated in the European directive for GCP (chapter 2-1-2) [25]. As our survey showed, educational levels at hiring and training of research personnel from hiring onwards, vary widely. This can be explained by the broad range of required educational levels for new recruits (see paragraph 3 of the Discussion section), a lack of standardisation of the university diplomas specific to CRA/CRT, and the relative newness of the jobs. Although training courses are offered to clinical research personnel in French hospitals, we now need to guarantee that such programs are easily accessible and that they cover all the essential competences, as described in the Joint Task Force for Clinical Trial Competency: scientific concepts and research design; ethics and safety; investigational products; GCP; study/site management; data management; leadership and professionalism; and communications/teamwork [26]. In addition, some ways to improve training need to be addressed in the future, such as having experience in data collection prior to work in monitoring, or being trained specifically to research in an ICU.

The main limitation of the current survey is that it targeted only a sample of the clinical research personnel of French ICUs and not the whole population. The situation in other medical specialties was not addressed either, but such a survey would have been more difficult due to the absence of the extensive network that exists between ICUs.