Site Executive, GCTO
Merck Sharp & Dohme Corp.
Chaoyang, CN
32天前

Description

  • Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies.
  • Communicates with sites on issues related to protocol conduct, enrollment / retention, protocol deviations, regulatory documentation, site audits / inspections, overall site performance, and financial payments.

  • Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, MSD global standards, local laws and regulations, including but not limited to review of informed consent, AE / SAEs, Health Authority documentation, and IMP supplies.
  • Performs source document verification of subject data and query resolution. Coordinate receipt and distribution of clinical trial supplies

  • Provides input to Site Selection utilizing site evaluation and validation processes.
  • Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

    Manages a full complement of sites with multiple protocols, depending on study / site complexity. Discusses the need for escalation of site performance issues with CRM, and supports audit / inspection activities as needed.

    申请
    申请
    邮箱地址
    通过点击 "继续 ", 我给 neuvoo 同意处理我的数据, 并给我发送电子邮件警报, 详细的 neuvoo 的 隐私政策 。我可以在任何时候撤回我的同意或取消订阅。
    继续
    申请表