• Performs site qualification, site initiation, interim monitoring, site management activities 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. • 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. • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information related to IP. • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. • Supports subject/patient recruitment, retention and awareness strategies. • Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. • Must be able to quickly adapt to changing priorities to achieve goals / targets. • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. • For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.