Site qualification, initiation, monitoring, and close-out
Source document review and data verification
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
Job Summary
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
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.
Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Matching Summary
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Skills & Requirements
Must-have
ICH-GCP and/or GPP compliance
Site qualification, initiation, monitoring, and close-out
Source document review and data verification
Investigational product management
Investigator Site File (ISF) review
Subject/patient safety and data integrity assessment
Nice-to-have
Agile and driven to deliver
Passionate problem solvers
Continuous learning and development
Inclusive and authentic culture
Key Requirements
Bachelor’s degree or RN in a related field
Knowledge of Good Clinical Practice/ICH Guidelines