Location: North America-United States
Job responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. 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.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements