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崗位職責(zé):
1. 監(jiān)查和數(shù)據(jù)管理：CRA負(fù)責(zé)按照研究方案和GCP（Good Clinical Practice）規(guī)范，對(duì)臨床試驗(yàn)項(xiàng)目進(jìn)行全面的監(jiān)查，確保數(shù)據(jù)的真實(shí)性、準(zhǔn)確性和完整性。這包括中心篩選、立項(xiàng)、倫理審查、啟動(dòng)、入組、日常監(jiān)查、數(shù)據(jù)清理和中心關(guān)閉等各個(gè)階段。
2. 項(xiàng)目管理：CRA協(xié)助項(xiàng)目經(jīng)理制定監(jiān)查計(jì)劃，掌握臨床試驗(yàn)方案，熟悉臨床電子管理系統(tǒng)的填報(bào)。
3. 物資和文件管理：負(fù)責(zé)試驗(yàn)藥品、物資、文件的申請(qǐng)和回收清點(diǎn)，確保試驗(yàn)文件的妥善保管和歸檔。
4. 溝通與協(xié)調(diào)：協(xié)調(diào)研究者、研究機(jī)構(gòu)、CRC、申辦方等，管理臨床試驗(yàn)事務(wù)。與研究中心的研究者進(jìn)行溝通，處理數(shù)據(jù)答疑等事宜，并跟進(jìn)試驗(yàn)過(guò)程中不良事件和嚴(yán)重不良事件的處理。
1. Monitoring and Data Management:The CRA is responsible for comprehensive monitoring of clinical trial activities in accordance with the study protocol and Good Clinical Practice (GCP) guidelines, ensuring authenticity, accuracy, and completeness of data. Responsibilities span all trial stages, including site selection, initiation, ethics review, activation, subject enrollment, routine monitoring, data cleaning, and site closure.
2. Project Management:Assist the Project Manager in developing monitoring plans, gain thorough understanding of the clinical trial protocol, and become proficient in using electronic clinical management systems for data entry and reporting.
3. Supplies and Documentation Management:Manage the requisition, retrieval, and inventory of investigational products, trial supplies, and documents. Ensure proper maintenance and archiving of all trial-related documentation.
4. Communication and Coordination:Serve as a liaison among investigators, research institutions, CRCs, and sponsors to facilitate clinical trial operations. Communicate with site investigators to address data queries and follow up on the management of adverse events (AEs) and serious adverse events (SAEs) throughout the trial process.

任職要求:
1. 教育背景：需要具備醫(yī)學(xué)、藥學(xué)、護(hù)理學(xué)、預(yù)防醫(yī)學(xué)、公共衛(wèi)生、醫(yī)學(xué)類(lèi)或相關(guān)生命科學(xué)專(zhuān)業(yè)背景，應(yīng)屆畢業(yè)生或無(wú)課程任務(wù)在校生。
2. 經(jīng)驗(yàn)：了解GCP及臨床試驗(yàn)行業(yè)者優(yōu)先。
3. 技能和能力：英語(yǔ)水平良好，熟悉辦公軟件使用，具備良好的組織協(xié)調(diào)、溝通談判能力，能夠積極、主動(dòng)地匯報(bào)工作進(jìn)展，并解決突發(fā)問(wèn)題。
4. 職業(yè)素養(yǎng)：能承受工作壓力，具備異地出差的適應(yīng)能力。
1. Education:Degree in Medicine, Pharmacy, Nursing, Preventive Medicine, Public Health, or related life sciences fields. Fresh graduates or current students without course conflicts are welcome to apply.
2. Experience:Prior knowledge of GCP and the clinical trial industry is preferred.
3. Skills and Abilities:Strong command of English; proficiency in office software applications; excellent organizational, coordination, communication, and negotiation skills. Ability to proactively report work progress and resolve unexpected issues.
4. Professional Attributes:Capable of working under pressure and adaptable to business travel as required.