CRA2 Information

Freelance CRA and projectmanagement. Fase II through IV clinical trials. Ethical submissions Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout Verifying that the investigator follows the approved protocol and all GCP procedures Project management Verifying that source data/documents and other trial records are accurate, complete, and maintained (SDV) Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs. Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects; Feasibility checks, locating and assessing the suitability of facilities at a study centre; setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards; training site staff to industry standards; monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis; writing visit reports; filing and collating trial documentation and reports. ensuring all used and unused trial supplies are accounted for as a blinded of unblinded monitor. closing down study centres on completion of the trial. archiving study documentation and correspondence.