医学监查员（美国认证胃肠病专家）
Medical Monitor (US Board-Certified 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相结合的完美平衡，同时也为员工提供这样的环境。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，美国
职责：
· 作为所有试验相关医学和安全问题的首要联系人
· 对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（IRBs）/独立伦理委员会（IECs）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
· 为试验团队提供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
· 进行操作性临床试验数据库的持续医学审查；为分配到该试验的医学评审员提供支持
· 审查方案偏离情况
· 审查严重不良事件（RAE）报告，撰写和/或审核严重不良事件（SAE）叙述，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
· 审查 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（如独立数据监控委员会（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团队对安全性和操作性临床试验数据库进行核对
· 审查临床研究报告（CSRs），包括安全性叙述和表格、图表及列表（TFLs）
· 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互动的活动
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 United States
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
- US Board Certification in Gastroenterology required
- Experience as a practicing Gastroenterology (minimum of 10 years)
- Clinical Research experience preferred
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
- For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.
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.