Farah Irani

Manager, Qa Cra @Retina Consultants of America

TX, US

Assesses site processes to facilitate execution of site-level activities and identify operational efficiencies and process improvements. • Provides guidance at the site and project level towards audit readiness standards.•Provides training or guidance to site staff on execution of study related activities to follow company SOPs, local and federal regulations, and guidelines.• Verifies site compliance with electronic data capture requirements, ICH/GCP Guidelines and other applicable guidance, relevant regulations, and company SOPs/processes.• Facilitates preparation and conducts review of study specific items for sponsor audits and FDA inspections.• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.• Documents QA Assessment activities via reports following QA Monitoring Plan to note and track all observations, ongoing status and assigned action items to resolution.• Conducts Source Document Review of appropriate site source documents and medical records to verify execution of critical study related activities, including obtaining informed consent, accurate and complete clinical data entry in the CRF.Ensures appropriate execution of all IP related activities is conducted following GCP/local regulations and organizational procedures.• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness to facilitate site reconciliation of ISF contents to ensure compliance with GCP.

University of Mumbai

Ph.D., Applied Biology

Kriger Research Center

Clinical project management

ASQ

Certified Quality Engineer

Academy of Diagnostics and Laboratory Medicine

FADLM, Lab Medicine

National Academy of Clinical Biochemistry

FAACC, Clinical Biochemistry

ASQ

Certified Quality Auditor

ASQ

Six sigma black belt