工作职责:
• Performs site qualification, site initiation, interim monitoring, site management activities close-out visits (performed on-site remotely) ensuring regulatory, ICH-GCP and/Good Pharmacoepidemiology Practice (GPP) protocol compliance. Uses judgment experience to evaluate overall performance of site site staff to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team develops action plans. Maintains a working knowledge of ICH/GCP Guidelines other applicable guidance, relevant regulations, company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed documented feach subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety clinical data integrity at an investigator/physician site such as protocol deviation/violations 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 medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate complete
o Applies query resolution techniques remotely on site, provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
o Utilizes available hardware software to support the effective conduct of the clinical study data review capture
o Verifies site compliance with electronic data capture requirements
• May perform investigational product (IP) inventory, reconciliation reviews storage security. Verifies the IP has been dispensed administered to subjects/patients according to the protocol. Verifies issues risks associated with blinded randomized information related to IP. Applies knowledge of GCP/local regulationsganizational procedures to ensure IP is appropriately (re)labelled, imported released/returned.
• Routinely reviews the InvestigatSite File (ISF) faccuracy, timeliness 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 regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, other required project documents as per SOPs Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention awareness strategies. Enters data tracking systems as required to track all observations, ongoing status assigned action items to resolution.
• Fassigned activities, understands project scope, budgets, timelines; manages site-level activities / communication to ensure project objectives, deliverables 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, in collaboration with Central Monitoring Associate. Ensures all assigned sites project-specific site team members are trained compliant with applicable requirements.
• Prepares fattends InvestigatMeetings and/sponsface to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsrepresentation, as applicable) attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site project level towards audit readiness standards supports preparation faudit required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines other applicable guidance, relevant regulations, company SOPs/processes; completes assigned training as required.
• FReal 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 freal world late phase study designs
o Chart abstraction activities data collection
o Collaboration with Sponsaffiliates, medical science liaisons local country staff
o The SMA II may be requested to train junistaff
o Identify communicate out of scope activities to Lead CRA/Project Manager
o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy Health Care Provider (HCP) associations
Qualifications
1、负责监查研究中心的入组进度、临床研究质量、临床试验工作协调，
2、确保临床试验严格遵循 GCP等相关法规及试验方案要求开展;
3、参与临床试验中心、研究基地、CRO的筛选、调研，建立与中心的联系和维护;
4、参与完成研究相关的合同签订、付款、器械物品管理、临床总结报告盖章等工作;
5、参与组织临床试验各阶段的会议;
6、协助统计人员进行数据管理和疑问表解答。
任职资格:
• Bachelor’s degree RN in a related field equivalent combination of education, training experience
• Knowledge of Good Clinical Practice/ICH Guidelines other applicable regulatory requirements
• Must demonstrate good computer skills be able to embrace new technologies
• Excellent communication, presentation interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis.
1、QS200强学校医药、护理、生物等相关专业本科及以上学历;
2、有较好的英语能力，英语workable（CET-6/IELTS 6.5/TOEFL 90/口译等）;
3、工作积极认真，执行力强，较强的协调沟通能力;
4、抗压能力强能够适应高频率出差。
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