高级站点管理专员
Senior Site Management Associate
我们是一家关注员工、客户、合作伙伴以及工作质量的公司。一家成立于1995年的充满活力的全球性公司，我们汇聚了3000多名有动力、有奉献精神且充满热情的个人。我们在医学科学的最前线工作，改变生命，并将新药带给需要的人。
职责范围包括：
· 处理所有非试验参与者相关和非方案相关的事项的主要联系人，包括供应商、试验物资和访问管理
· 管理与站点和非现场设施的记录流程
· 准备监管和伦理委员会提交/通知文件及记录
· 协调向站点和非现场设施支付款项
· 准备并跟进站点审计和检查
· 与监查员和站点协调处理站点特定的问题解决
· 审核站点特定的EDC完成进度，并定期向监查员提供更新
· 在行政站点相关问题上作为其他公司部门的主要联系点
· 组织、参与并准备内部项目团队会议的报告
· 与站点和项目团队合作组织研究者会议
· 在监督下，对站点管理人员I & II和临床运营行政支持人员进行现场指导
· 安排并跟踪研究者站点团队在所有供应商相关系统中的初始和持续培训
· 向研究者站点提供快递管理和试验物资订购的培训
· 将试验记录归档到TMF，并在站点和国家层面进行定期的TMF检查
· 参与并跟进TMF和系统审计
· 准备、分发和更新研究者站点文件（ISF）和ISF检查清单
· 协调站点和国家层面的试验记录翻译流程
· 收集IP-REDs并整理IP-RED包以供进一步审查
· 所有非试验参与者相关事项的主要供应商联系人，包括供应商系统的前期测试
· 在站点、国家/地区层面跟踪供应商相关物资
· 与供应商交换信息和记录
- 具备大学或以上学历，或具有同等教育、培训和经验组合，能够展示所需的知识、技能和能力。
- 至少3年临床研究行业经验，CRO前
查看英文原文
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
The scope of responsibilities will include:
· Main site contact for all non-trial-participant related and non-protocol
related issues, including vendors, trial supplies and access management
· Manages records flow with sites and off-site facilities
· Prepares regulatory and ethics committee submission/ notification
documents and records
· Coordinates payments to sites and off-site facilities
· Prepares for and follows up on site audits and inspections
· Reviews and coordinates site-specific query resolution with Monitors and
sites
· Reviews site-specific EDC completion progress and provides the Monitor
with regular updates
· Serves as the main contact point for other company departments in
administrative site-related issues
· Organizes, participates in, and prepares reports of internal project team
meetings
· Collaborates with sites and project team on Investigator Meetings'
organization
· Under supervision, provides on-the-job coaching of Site Management
Associates I & II and Clinical Operations Administrative Support staff
· Arranges and tracks initial and ongoing trial training for investigator site
teams in all vendor-related systems
· Provides training in courier management and trial supplies ordering to the
investigator sites
· Files trial records in the TMF and performs regular TMF checks on a site and country level
· Participates in and follows up on TMF and systems audits
· Prepares, distributes, and updates Investigator Site Files (ISF) and ISF
checklists
· Coordinates the translation process for trial records on a site and country
level
· Collects IP-REDs and compiles IP-RED packages for further review
· Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems
· Tracks vendor-related supplies on a site, country/regional level
· Exchanges information and records with vendors
- College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
- Minimum 3-year experience within the clinical research industry, CRO preferred, in similar role or equivalent to Site Management Associate II
- Basic proficiency in MS Word.
- Basic proficiency in MS Excel.
- Basic proficiency in MS Outlook.
- Basic proficiency in MS Power Point.
- Knowledge (following proper training) of applicable software and project specific systems.
Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.