Clinical Trial Coordinator

10 hours ago

Noida, Uttar Pradesh, India beBeeResearch Full time ₹ 12,00,000 - ₹ 25,00,000

Study Facilitation

  • The primary role is to ensure the integrity of clinical trials by providing timely inputs in the protocol and Informed Consent. This includes a detailed description of trial-related activities ensuring that it is scientifically sound.
  • The process involves submitting protocol and other required study-related documents to the Ethics Committee (as per the Ethics Committee SOP) to guarantee study commencement only after obtaining IEC and DCGI approval.
  • Ensure all conditions are fulfilled prior to commencement of the study in case of conditional approval of IEC.
  • Complete Form 1572 and 3454 as per SOP CL-G009 for US submission studies.
  • 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.
  • Adequate facilities and resources must be available for proper conduct of the study.
  • Conduct the study according to the EC-approved protocol, in-house SOPs, and applicable regulatory requirements.
  • Inform the volunteer about the study and its procedures, encourage the volunteers to ask questions and answer their questions in their vernacular language prior to obtaining their written informed consent.

Key Responsibilities:

Functional Area: Clinical research, data monitoring, data integrity, medical and clinical recruitment agencies, research and development jobs, scientist jobs, clinical research jobs.

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