・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 Practices (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
・Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
・Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
・Must demonstrate good computer skills and be able to embrace new technologies
・Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected
・Ability to manage required travel of up to 75% on a regular basis