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Clinical Research Scientist

2 months ago

noida, India Seven Consultancy Full time

JOB DETAILS


1 To provide timely inputs in the protocol and Informed Consent (for e.g. dosing information, contraindications, warnings, precautions, adverse events, and drug interactions) and thus ensure it is scientifically sound and gives a clear detailed description of trial related activities.
2 To submit protocol and other required study related documents to the Ethics Committee (as per the Ethics Committee SOP and ensure study commencement only after obtaining IEC and DCGI approval.
3 Ensure all conditions are fulfilled prior to commencement of the study in case of conditional approval of IEC.
4 In case of US submission studies, complete form 1572 and 3454 as per SOP CL-G009.
5 To train and delegate trial related duties to all study personnel prior to start of the study or prior to performing any study specific activity and document the same in Form No.01.
6 To ensure adequate facilities and resources are available for proper conduct of the study.
7 To ensure that the study is conducted as per the EC approved protocol, in-house SOPs and applicable regulatory requirements.
8 To inform the volunteer about the study and its procedures, encourage the volunteers to ask questions and answer their questions in their vernacular language (or with the help of transistor) prior to obtaining their written informed consent
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