Senior Clinical Research Associate (Oncology Experience Required) - Paris

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company are seeking sponsor dedicated Senior Clinical Research Associates, to be based in the Paris region, France. Experience in oncology trials and RECIST reputed company is essential. The Senior CRA will be responsible for data reputed company, data reputed company and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed reputed company for the reputed company of activities to supplement on site visit requirements. The Senior CRA will collaborate with the Site Manager to assure that the site complies with the protocol and is inspection reputed company and will coordinate with institutions and investigators at the local level. Some specifics about this advertised role reputed company of Monitoring Responsibilities and Study Conduct Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops reputed company plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company reputed company Operating Procedures (SOPs)/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject as required. Demonstrates diligence in protecting the confidentiality of reputed company subject and assesses factors that might reputed company subject safety and clinical data reputed company at an investigator site such as protocol deviation and violations and pharmacovigilance issues. Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different reputed company, (e.g., both on site and remote) where allowed by country regulations. Conducts reputed company document review and verification of appropriate site reputed company documents and medical records. Verifies required clinical data entered in the Case Report reputed company (CRF) is accurate and complete. Manages reporting of protocol deviations and appropriate follow up. Applies query reputed company techniques remotely and on site, and provides guidance to site staff as necessary, driving query reputed company to closure reputed company agreed timelines. May reputed company Investigational Product (IP) inventory, reconciliation and reviews storage and reputed company. Verifies the IP has been reputed company and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information reputed company to IP. Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned. Manages reporting of identified issues and manages follow up to reputed company. Documents activities reputed company follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP. Ensures reputed company activities are managed by site personnel who are appropriately delegated and trained. Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company. For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. (Must be reputed company to quickly adapt to changing priorities to reputed company goals and targets). Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer reputed company on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.) .