CRA

Advity Research; Hyderabad; On-site; INR 300,000 - 550,000; Full time

Job summary

Advity Research in Hyderabad is seeking a diligent Clinical Study Coordinator to manage study documentation, TMF readiness, and regulatory submissions during the conduct of clinical studies. You will liaise with QA, PIC/PI and study staff to ensure SOP compliance, data integrity, and timely archiving of ICDs, CRFs and TMFs, while supervising CRTs and RNs.

The role emphasizes meticulous document control, SOP deviations reporting, and adherence to protocol with a focus on quality assurance

Responsibilities

• Request and receipt of study specific documents from QA.
• Compilation of study specific TMF (prior to study).
• Readiness of the CPUs with the support of HK staff.
• Place indents to procure material / supplies needed for the study.
• Place indents to procure material / supplies needed for the study.
• Self-checking of protocol training completion.
• Providing ICD presentations to volunteers in groups.
• Perform admission, discharge, meal distribution, reporting, and monitoring of subjects during the clinical study conduct.
• Supervision of activities of other study personnel (CRTs, RNs) during the conduct of clinical study.
• Compilation and review of study data and ensuring the compliance with SOPs and protocol during the study conduct.
• Compilation of study documents on timely.
• Responsible for submission of study documents (ICDs, CRFs and TMFs) to QC, QA for review and subsequent closure of observations in consultation with Study PIC/ PI or designee.
• Assist the PIC for the archiving of study documents.
• Identification of the SOP / protocol deviations and bring it to the notice of project in-charge for recording.
• Compliance and data integrity during study execution with SOPs and regulatory requirements.

Job description

• Request and receipt of study specific documents from QA.
• Compilation of study specific TMF (prior to study).
• Readiness of the CPUs with the support of HK staff.
• Place indents to procure material / supplies needed for the study.
• Place indents to procure material / supplies needed for the study.
• Self-checking of protocol training completion.
• Providing ICD presentations to volunteers in groups.
• Perform admission, discharge, meal distribution, reporting, and monitoring of subjects during the clinical study conduct.
• Supervision of activities of other study personnel (CRTs, RNs) during the conduct of clinical study.
• Compilation and review of study data and ensuring the compliance with SOPs and protocol during the study conduct.
• Compilation of study documents on timely.
• Responsible for submission of study documents (ICDs, CRFs and TMFs) to QC, QA for review and subsequent closure of observations in consultation with Study PIC/ PI or designee.
• Assist the PIC for the archiving of study documents.
• Identification of the SOP / protocol deviations and bring it to the notice of project in-charge for recording.
• Compliance and data integrity during study execution with SOPs and regulatory requirements.