Clinical Research Associate

The Indus Hospital


Date: 1 day ago
City: Lahore
Contract type: Full time
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.”

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