Job duties of CRC

Ethics committee liaison: liaising with the ethics committee and managing related documents. Informed consent: explaining the trial to patients and assisting investigators in obtaining informed consent. Patient and family education, liaison, counseling and negotiation: act as a liaison with patients and their families before signing the informed consent, during and after the trial, responsible for disease management education, counseling in case of adverse events, etc., involving medical and non-medical issues (e.g., costs, compensation, etc.). Liaison and reception of sponsors (including CROs): liaise and negotiate with sponsors on various matters; liaise, coordinate and manage the upgrading of protocols, CRFs, informed consents, etc.; respond to supervisory inspections (including verification of original data) and audits; prepare and provide sponsors (including CROs) with the required documents, e.g., laboratory normal value ranges, ethical committee approvals, researcher's authorization forms, etc. The following are some examples of such documents Implementation of Clinical Trials 1) Screening and Enrollment of Subjects: Arrange screening tests according to the protocol, discuss and judge the suitability of the enrolled trial with the investigator***. Patients who meet the conditions for enrollment will be enrolled in accordance with the procedures stipulated in the discussion plan, and will be given a trial code and a randomization code (blinded trial).  2) Management of the trial process: Coordinate the schedules of the subjects and the investigating physicians according to the consultation time window stipulated in the protocol, and arrange the consultation.  3) Management of source material such as medical records.  4) CRF completion (not related to clinical judgment, transcription from source material), remote data entry or EDC data entry (if applicable).  5) Reconciliation of CRFs with original data, discussing problems identified with study physicians.  6) Clinical examination: management of clinical laboratory specimens, especially for specimens sent to the central laboratory, centrifugation and other pre-processing, and to ensure that the specimens are preserved in accordance with the regulations before shipment; the implementation of certain physical examination: such as temperature, blood pressure, electrocardiography, etc.; management of clinical examination results: the discovery of abnormal results or changes in the abnormal, and timely report to the investigator; the sponsor-provided examination equipment storage, management.  7) Adverse events: ① Discover, report (sponsor, IRB and related parties), investigate, track and record adverse events through more contact with subjects. ② CRCs with medical and pharmacy backgrounds assist the investigator in determining the extent, causality, and relationship of adverse events. (iii) Handle adverse events according to the investigator's instructions.  8) Management of trial drugs and drugs used in the trial: ① Instruction of drug taking, confirmation and recovery of remaining drugs, calculation of drug adherence. ② Record and management of combined medication.  9) Response in case of trial termination, interruption, or case loss. Document management: archiving documents that should be kept by the trial implementation organization.