医疗监测员（胃肠病学家）
Medical Monitor (Gastroenterologist)
PSI 是一家领先的合同研究组织，拥有超过 30 年的行业经验，为客户提供稳定与创新的完美平衡，也为员工提供良好的工作环境。我们专注于在多种治疗领域按时交付高质量的服务。
PSI Medical Monitors 为全球临床研究提供医学支持，并向团队和业务合作伙伴提供建议，始终关注患者的用药安全和健康状况。
居家办公地点：阿根廷
职责：
· 作为所有与试验相关的医学和安全问题的首要联系人
· 就试验相关的医学和安全问题向监管机构和机构审查委员会（IRB）/独立伦理委员会（IEC）提供回复意见
· 监测试验参与者的安全状况
· 参与试验参与者招募和留存活动
· 在启动会议和研究者会议上就医学相关事项进行汇报
· 对试验团队进行治疗领域和方案医学方面的培训
· 在医学监测范围内制定和审核试验相关文件
· 管理与医学监测相关的持续试验风险
· 进行临床试验数据库的持续医学审查；为分配到该试验的医学审查员提供支持
· 审核方案偏离情况
· 审核不良事件报告，撰写和/或审核严重不良事件描述，协助药物警戒团队处理未决的安全性问题，与申办方沟通现场安全性问题
· 审核 IND/SUSAR 安全报告，更新/修改关键试验记录和年度 IND 报告（根据申办方要求）
· 根据相应的试验特定章程，参与试验相关委员会（如独立数据监测委员会（IDMC）/裁定委员会）的管理工作
· 协助药物警戒、医学数据审查和数据管理，对安全性和操作性临床试验数据库进行对账
· 审核临床研究报告（CSR），包括安全性描述和表格、图形和列表（TFL）
· 在医学监测不是合同交付物的试验中，按需提供医学专业知识
· 准备并参与试验审计，跟进审计发现
· 参与国家/地区内潜在和正在进行的试验的可行性评估
· 参与投标答辩会议和其他与客户的互动
查看英文原文
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Home-Based in Argentina
Responsibilities:
· Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
· Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
· Monitors trial participant safety
· Participates in trial participant recruitment boost and retention activities
· Presents on medical matters at kick-off and investigator meetings
· Trains trial team in the therapeutic area and medical aspects of the protocol
· Develops and reviews trial-specific documents within the scope of medical monitoring
· Manages ongoing trial risks related to medical monitoring
· Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
· Reviews protocol deviations
· Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
· Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
· Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
· Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
· Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)
· Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
· Prepares for and participates in trial audits, follows up on audit findings
· Participates in feasibility assessment of potential and ongoing trials in the country/region
· Participates in bid defense meetings and other interactions with clients
· Acts as a medical expert and provides therapeutic expertise to other PSI departments
- Medical Doctor degree required
- Experience as a practicing Gastroenterologist (minimum of 10 years)
- Clinical Research experience preferred
- Full working proficiency in English and Spanish
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.