Clinical Research Associate

Job DescriptionRegular updates to study management about site performance. Correspondence with the study manager on site-related issuesComplete site file review and documentationResponsible for providing all safety information of all clinical trials to the Ministry of Health according to the Ministry timelinesAdditional 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 guidelinesTo conduct Trial according to the Study Protocol with given/assigned Delegated taskExperience for IRB-Institution Review Board, Submissions & approvals with Documents of the original version and amendments by the sponsorTimely 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 dataClose and timely Correspondence & coordination with the PI-Principal Investigator, Sub-Investigator, and department management.

Close communication with the patients enrolled in the studyClose and timely Correspondence & coordination with the international study team, including Data Manager, Study Manager, and Pharmacovigilance departmentsPreparation of CRF-Case Report FormsDaily updating the e-CRF, Electronic Case Report FormsExperience 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. ”