Clinical Research (Qc)
Hyderabad, Telangana, India
• To perform QC of ICD (versus Protocol), study protocols, compensation chart and other study related documents, prior to submission of documents to IEC/IRB and ensure that approval of IEC/IRB for the study protocol and related documents are available before commencement of the clinical study.• Ensure that the requisite stock of consumables required for the clinical study (e.g. labelled vacutainers, ria/ cryo vials, IV cannula etc) is available.• To perform the online monitoring of dosing, sample collection, sample processing, segregation of the bio samples.• Review the Case Report Form (CRF) according to IEC approved protocol and provide inputs. Prepare study plan and ensure that all the study personnel are trained on the protocol and the study related activities.• To perform review of AE forms which issue occurred during study and post study. And verify the concomitant medication accountability against with the ICU medicines.• To identify and reporting protocol deviations in study documents.• To coordinate with bioanalytical department for any specific sample treatment during study (e.g. addition of buffer or handling procedure).• Ensure that all the activities are performed by delegated staff personnel in compliance with the EC approved protocol, GCP, relevant SOP’s and applicable regulatory requirement. To ensure/Keepaccountability of all controlled study documents during clinical conduct of study till its submission to the QAU. Ensure proper documentation of the protocol/SOP deviation and note to file