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.
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
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 and initiation
Monitoring and close-out visits
Informed consent verification
Subject safety and data integrity assessment
Source document review
Investigational product verification
Investigator Site File review
Nice-to-have
Develops action plans for issues
Supports subject recruitment strategies
Adaptable to changing priorities
Guidance towards audit readiness
Key Requirements
Bachelor’s degree or RN in a related field
Knowledge of Good Clinical Practice/ICH Guidelines