Job Description
Regular updates to study management about site performance.
Correspondence with the study manager on site-related issues
Complete site file review and documentation
Responsible for providing all safety information of all clinical trials to the Ministry of Health according to the Ministry timelines
Additional training for employees ensures that all procedures are followed across all product lines.
Experienced for Timely management of the clinical trial as per ICH/GCP guidelines
To conduct Trial according to the Study Protocol with given/assigned Delegated task
Experience for IRB-Institution Review Board, Submissions & approvals with Documents of the original version and amendments by the sponsor
Timely reporting of SAEs, Serious Adverse Events, in the study, to the sponsor and IRB/Ethics Committee (EC).
Timely reporting, submissions of SUSAR, Serious Unexpected Serious Adverse Reaction(s), of international clinical and non-clinical data
Close and timely Correspondence & coordination with the PI-Principal Investigator, Sub-Investigator, and department management.
Close communication with the patients enrolled in the study
Close and timely Correspondence & coordination with the international study team, including Data Manager, Study Manager, and Pharmacovigilance departments
Preparation of CRF-Case Report Forms
Daily updating the e-CRF, Electronic Case Report Forms
Experience with IVRS (Interactive Voice Response System at different stages of the study, (Screening, Enrollment, and Premature Termination).
Note: “Indus Hospital & Health Network is an employer that does not tolerate Sexual Exploitation and Abuse. All potential candidates will be subjected to rigorous background checks and controls.”