Table 3.

Job skill requirements of clinical research nurses with different professional titles.

Professional ranks and titles	Knowledge and skills	Specific requirements
Primary	Facilities management Training and education Project planning and implementation Subject management Safety monitoring Investigational drug management Investigational device/reagent management Sample management Data management Contract and funding Management Essential document Material handling Communication and coordination Nursing skills required for the program	•Obtain the annual quality inspection report of the common test equipment in a timely fashion. •Confirm whether the equipment required for project implementation is complete •Check with the PI and the sponsor whether the supplementary equipment is required according to the project requirements •Return the special equipment provided by the sponsor •Complete training on laws and regulations related to research •Be familiar with the basic knowledge of disease medicine related to research •Have communication skills, foreign language skills and computer skills •Improve the necessary nursing professional knowledge and skills for clinical research •Engage in various research meetings, master the test requirements, and follow-up the research progress •Project initiation application and follow-up •Ethics committee review application and follow-up •Contract review application and follow-up •Application for internal platform resources in the Research Center •(eg, pathology, examination, imaging, and pharmacy)" •Assist in preparing, organizing, and holding the kick-off meeting •Confirm that the members of the research team have been trained and authorized •Contrive and continuously optimize the project implementation process •Develop various worksheets •Assist in recording and reporting protocol violations •Assist in submitting annual reports •Submit CRF, drug test report, IB, and other project-related documents •Assist in reviewing/submitting project summary and summary report •Assist in screening subjects •Informed consent in the qualification •Complete the randomization/enrollment procedure of subjects •Appointment and arrangement of visit procedures (eg, examination, treatment, and follow-up of subjects) •Offsite communication and follow-up by telephone or other means of communication •Tracking and recording of concomitant treatment and medication during the study of subjects •Closely observe the tracking and recording of the patient's condition changes •Survival follow-up •Subject education •Finding and observing adverse events of subjects •Assist in collecting, reporting, tracking, and recording security incidents •Assist researchers in timely reporting SAE •Assist researchers to submit SUSAR in time •Receipt, storage, distribution, return/destruction of drugs •Receiving, configuration and use of trial drugs •Storage of trial drugs in clinical departments, warehousing registration, and return •Drug dose calculation and verification •Instruct subjects to fill in medication records •Medication compliance management •Obtain drug test reports regularly •Check the expiry date of the trial drug and replenish the inventory in time •Ensure that the storage environment of test instruments/reagents meets the requirements •Receive, manage and return test instruments/reagents according to hospital management requirements •Receiving and use of test instruments •Receive training on the use of test instruments/reagents •Inventory management, stock replenishment application, and warehouse in and warehouse out registration •Assist in the counting, destruction, recycling, and recording of test reagents •Receipt, inspection, use and warehousing management of consumables related to samples •Sample collection/collection, processing, storage, transfer, and warehousing registration• records of sample management process •Issue, recover, and save diary cards and questionnaires •Fill out the CRF •Answer data queries •Research-related data copy and transmission •Contract review, submission, and signing •Fund injection and expenditure management •Reimbursement and management of subjects' related expenses •Collect and save bills related to project funds •Confirm project document management requirements •Investigator folder preparation •Collect, save, maintain, and update clinical research process documents and original data documents •Filing and return of research documents •Management of project-related materials (eg, document supplies and consumables) •Confirm and supplement corresponding materials with the sponsor in accordance with the requirements of clinical research •Regularly check inventory and effectiveness and timely replenishment •Timely liquidation and return of relevant materials •Coordinate and communicate with institutional offices and ethics committees •Coordination and communication with the research team •Coordinate and communicate with the sponsor and CRO/SMO •Coordination and communication of supervision, inspection, internal inspection, and verification •Identify and solve operation problems in time •Nursing physical examination, treatment, and medication nursing related to clinical research •Condition observation and psychological care •Health education for patients and their families related to diseases and research •Nursing work in experimental ward
Intermediate	Facilities management Training and education Project planning and Implementation Subject management Safety monitoring Investigational drug management Sample management Data management Contract and fund management Material management Communication and coordination Nursing skills	•Confirm the routine equipment maintenance and calibration work of the test institution •Manage the project specific equipment provided by the sponsor according to the hospital regulations •Understand clinical research methods and statistics •Project training (eg, program and SOP) •Assist PI in formulating/reviewing research protocol, informed consent, CRF and other documents •Human genetic resources management •Assist researchers to set up research teams according to project needs •Contrive and continuously optimize the project implementation process •Develop and continuously optimize research work forms •Organize the research team to discuss the combined medication and treatment plan •Follow up the plan violation and continuously optimize the implementation process •Write/review annual reports •Review the project summary and summary report •Assist in the recruitment of subjects •Check the qualification of subjects •Assist researchers in dealing with adverse events •Provide adverse event nursing guidance and education to subjects •Assist in the management of the central pharmacy/satellite pharmacy of the experimental institution •Ensure that the storage environment of the test drug meets the requirements •Train the executors of the trial drugs (dispensing and injection) according to the scheme •Develop sample management process •Discuss and confirm the source data file of the research project with the researchers •Ensure data authenticity, logic, and other quality management work •Accounting of project funds •Manage materials according to hospital regulations, report registration and use records •Internal platform department coordination and affairs communication of the test institution (affairs communication of pharmacy, finance, information, inspection, and other medical technology departments) •Emergency care
Senior	Project planning and implementation Contract and fund management	•Assist PI in formulating/reviewing research protocol, informed consent, CRF and other documents •Complete first level quality control •Project budget •Evaluate the operation process and improvement of the test institution (system construction)

PI, principal investigator; SOP, Standard Operation Procedure; CRF, case report form; IB, Investigator’s Brochure; SAE, severity adverse event; SUSAR, suspected unexpected serious adverse reaction; CRO, contract research organization; SMO, site management organization.