临床监查员CRA I(Core Team)

61 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

61 Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely

61 Provides regular site status information to team members, trial management, and updates trial management tool.

61 Completes monitoring activity documents as required by Company or Sponsor SOPs or other contractual obligations

61 Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues

61 Escalates site and trial related issues per Company SOPs, until identified issues are resolved or closed

61 Performs essential document site file reconciliation

61 Performs source document verification and query resolution

61 Assesses IP accountability, dispensation, and compliance at the investigative sites

61 Verifies Serious Adverse Event (SAE) reporting according to trial specifications and relevant local and ICH GCP guidelines

61 Communicates with investigative sites

61 Updates applicable tracking systems

61 Ensures all required training is completed and documented

61 Be assigned logistical support tasks by CTM for Investigator Meetings

任职要求：

61 Education

Undergraduate degree or its international equivalent in clinical, science, or health‐related field from an accredited institution; a licensed health‐care professional (i.e., registered nurse); or equivalent work experience required

61 Experience

1to 2 years of local trial experience; exposure to MNC and global trials

61 Preferred Education and/or Experience

Clinical research experience

Knowledge of ICH and local regulatory authority regulations regarding drug

An advanced degree (e.g., M.S.,M.B.A., PharmD, etc.)