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FSP-CRA1/2臨床監(jiān)查員

1.3-2萬(wàn)·13薪
  • 鄭州金水區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招1人

職位描述

藥品臨床監(jiān)查
Key Role and Responsibilities Summary:
  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of
    clinical trials, and close clinical trials at investigative sites.
  • Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
  • Provides regular site status information to team members, trial management, and updates trial management tools,
  • Completes monitoring activity documents as required by SOPs or other contractual obligations.
  • Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
  • Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
  • Performs essential document site file reconciliation.
  • Performs source document verification and query resolution.
  • Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
  • Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
  • Communicates with investigative sites
  • Updates applicable tracking systems.
  • Ensures all required training is completed and documented
  • Serves as main observer/assessor of site activities.
  • Facilitates audits and audit resolution.
  • To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.
  • Mentors’ junior-level CRAs and serve as a resource for new employees.
  • Serves as main observer of site activities and may have some responsibilities for performance of site.
  • May be assigned additional clinical operations tasks.
  • May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
  • May be assigned clinical tasks where advanced negotiating skills are required.

工作地點(diǎn)

金水區(qū)鄭州大學(xué)第一附屬醫(yī)院(鄭東院區(qū))

認(rèn)證資質(zhì)

營(yíng)業(yè)執(zhí)照信息

職位發(fā)布者

羅鈺瑩/人事經(jīng)理

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