Cra / Crc / Monitoring - Clinical Trials

Department: Clinical Trials Education Qualification: Any Science Graduate Job Type: At Clinical Trials site Job Description Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis. Planning and ensuring the availability of allocated study specific requirements including resources, consumables etc. Ensuring the availability of all essential documents (prior to study initiation) for allocated studies. Coordination for retention, sending back or destruction at the Pharmacy. Review and supervision of TMF filing across the study duration. Supervision and ensuring that all study activities are carried out in compliance with in-house SOPs and approved protocol. Responsible for ensuring adequate quantity of IMPs to conduct clinical trials. Responsible for ensuring IMP supplies, accountability, and retention quantity at the study centre. Designing data collection forms, known as case record forms (CRFs). Discussion on the process of obtaining informed consent form and documentation. Verifying the documentation of the informed consent process for each study subject. Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as Source Data/Document Verification (SDV). Collecting completed CRFs from hospitals and general practices. Writing visit reports. Closing down study centres on completion of the trial. Archiving study documentation and correspondence. #J-18808-Ljbffr