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項目及治療領域： 負責global II/III期非腫瘤項目

公司提供豐厚的薪資福利: 五險一金，補充公積金，生日/節假日禮品券，spotlight積分兌換商品 額外津貼：住房補充，交通，餐飲，采暖（僅適用于中國北方地區）等各種津貼 員工健康：補充商業醫療保險，年度健康體檢 長期發展：內部轉崗機會，豐富的線上線下培訓 專業培訓：Clinical Training Institute的專業支持，賽紐仕的CRA培訓計劃由IAOCR認證并頒發相應證書

Job responsibilities ? 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): o Assesses site processes o Conducts Source Document Review of appropriate site source documents and medical records o Verifies required clinical data entered in the case report form (CRF) is accurate and complete o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture o 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. Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate out of scope activities to Lead CRA/Project Manager o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations Qualifications What we’re looking for ? Bachelor’s degree and or above degree with major in medicine/healthcare/life science related ? 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 ? Ability to manage required travel of up to 75% on a regular basis Syneos Health賽紐仕醫藥是一家全面整合生物制藥解決方案的公司，旨在幫助客戶加快推出新療法的速度。我們站在產品研發的角度，戰略性地融合臨床研發、醫學事務和商業能力，以及時應對最新市場變化。 想了解更多關于我們如何縮短從實驗室到現實生活的距離，請訪問官網或訂閱我們的播客。