Perform site qualification, initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
Job Summary
Perform site qualification, initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
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
Perform site qualification, initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
Skills & Requirements
Must-have
ICH-GCP and GPP compliance
Site qualification and initiation
Interim monitoring and close-out visits
Source document review
Investigational product verification
Investigator Site File reconciliation
Nice-to-have
Agile and driven to deliver
Passionate problem solvers
Inclusive culture
Adapt to changing priorities
Key Requirements
Bachelor’s degree or RN
Knowledge of Good Clinical Practice/ICH Guidelines