Clinical Trial Monitor
Sidra Medicine
منذ 6 يوم
source :

Key RoleAccountabilities

  • Ensures that the Investigator and study team follow theapproved protocol and all approved amendment(s), if any, and adhereto current regulations, applicable ICH / GCP guidelines, localpolicies and standard operating procedures, including Monitoringstandards and guidelines.
  • Ensures that theinvestigator and the investigator's study team areperforming the specified trial functions, in accordance with anyother written agreement between the sponsor and the investigator,and have not delegated these functions to unauthorizedindividuals.
  • Adheres to theprotocols’ Data Safety Monitoring Plans; e.g. monitoringvisit type, frequency, and required critical monitoring activitiesby utilizing monitoring tracking forms and other monitoring relatedtools and templates.
  • Assists in thedevelopment and writing of clinical trial monitoringplans.
  • Verifies that the investigator receivesthe current Investigator's Brochure, all documents, and alltrial supplies needed to conduct the trial properly and to complywith the applicable regulatory requirements.
  • Verifies that the investigator has adequatequalifications and resources and remains adequate throughout thetrial period.
  • Validates that the investigatorand the investigator's study team are adequately informedabout the trial.
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