職位描述
Major responsibilities Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office and at site.Actively participate in local Study Delivery Team meetings.Contribute to the selection of potential investigators.Train, support and advise Investigators and site staff in study related matters.Contribute to national Investigators meetings.Initiate monitor and close study sites in compliance with AZ Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.Update IMPACT and other systems with data from centres as per required timelines.Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.Perform source data verification according to SDV plan.Ensure data query resolution.Ensure accurate and timely reporting of Serious Adverse Events.Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.Provide the required monitoring visit reports within required timelines.Work with data management to ensure quality of the study data.Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).Additional Responsibilities May IncludeEnsure completeness of the Study Master File and ensure essential documents are sent to R&D site.Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.Ensure timely customization and completion of the CSA for designated studies.Design draft budget for designated studies according to fSMA requirementsTrack and manage agreed payments at study site level.Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.Contribute to process improvements, knowledge transfer and best practice sharing.Actively share applicable information that may be relevant to Marketing & Sales and the MC Medical Departmentand in accordance with Corporate Ethical guidelineEducation, Qualifications, Skills and ExperienceUniversity degree in biological science or healthcare-related field, or equivalentExperience as a MC CRA/ clinical monitor, performed all tasks for a CRA position · Understanding of the clinical dataflowVery good knowledge of the clinical study and drug development processes, GCP/ICH guidelinesComputer proficiencyVery good knowledge of spoken and written English【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.阿斯利康是一家提供平等機會的企業，我們將考慮所有符合條件的求職者就業。不因殘疾、性別或性取向、懷孕或產假狀況、種族或民族或族裔出身、年齡、宗教或信仰、性別認同或變更、婚姻或伴侶關系、受保護的退伍軍人身份（如果適用）及任何其他受法律保護的特征而產生歧視。】
