Table 1 Job description of the clinical research personnel as defined by the French Ministry of Health (2023)
Jobs and related tasks | Abbreviation |
|---|---|
Clinical research assistant | CRA |
Designing and building tools or methods | Tools&Meth |
Checking application of rules, procedures, norms, and standards | RPNS |
Checking conformity/validity of documents | CVDoc |
Checking logistical feasibility of the study | Feasibility |
Checking and monitoring the quality of process(es) | Quality |
Organising events such as meetings, visits, and specialised committees | Events |
Drafting reports on observations/interventions | Reports |
Monitoring adverse events | MonAEs |
Clinical research technician | CRT |
|---|---|
Checking feasibility of the study’s logistical circuits | Circuits |
Establishing/updating, and implementing processes, procedures, protocols, and instructions | PPPI |
Managing (browsing, collecting, analysing, prioritising, sharing, filing, tracking) data and information | Manage D&I |
Informing/advising the caring staff, patients, families, etc. | Communication |
Organising data checking before monitoring visits | Pre-visit |
Preparing biological sampling, storage, and shipping | PrepBiol |
Assessing and presenting the clinical activity of the unit | ClinActiv |
Gathering data or information | Gather D&I |
Completing documents and files (activity or traceability sheets, etc.) | CompletDoc |
Reprography, anonymising results, and transmitting data to the coordinating centre | HandleDoc |
Reporting/tracking adverse events | RepAEs |
Dispatching study documents (recording, sorting, processing, distribution, archiving) | DispatchDoc |
Pre-analytical treatment of samples | Samples |
Clinical research project manager | CRPM |
|---|---|
Checking application of rules, procedures, norms, and standards | RPNS |
Checking meeting of deadlines (products, files, interventions, etc.) | Deadlines |
Supervising team(s), staff management, and implementation | Supervision |
Establishing/updating and implementing processes, procedures, protocols, and instructions | PPPI |
Drawing up specifications according to customer’s requirements | Customer |
Planning activities and resources; control and reporting | Planning |
Finding/managing the financial, human, and logistical resources | Resources |
Managing grant application files and calls for tender | Grants |