Clinical Research Scientist

Responsibilities:

• Provide timely inputs on the protocol and Informed Consent, including dosing information, contraindications, warnings, precautions, adverse events, and drug interactions to ensure scientific accuracy and clarity of trial activities.
• Submit the protocol and other required study documents to the Ethics Committee (IEC) as per SOPs; ensure study commencement only after obtaining IEC and DCGI approval.
• Ensure all conditions are met prior to study initiation in case of conditional IEC approval.
• For US submission studies, complete Forms 1572 and 3454 according to SOP CL-G009.
• Train and delegate trial-related duties to study personnel before study initiation or before performing any study-specific activity; document training in Form No.01.
• Ensure adequate facilities and resources are available for proper conduct of the study.
• Conduct the study according to EC-approved protocol, in-house SOPs, and applicable regulatory requirements.
• Inform volunteers about the study procedures, encourage questions, and provide clear explanations in their vernacular language (or with assistance) prior to obtaining written informed consent.