Lambda Canada | QC Data Reviewer
14168
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QC Data Reviewer

POSITION SUMMARY:         

Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness, and consistency according to Protocol, SOPs and Regulatory requirements.

KEY RESPONSIBILITIES:
  • Review study files after completion and ensure that they are accurate and legible according to Protocol, SOPs and Regulations
  • Ensure all prepared study source documents and/or Forms are in accordance to protocols and SOPs
  • Perform live QC during the conduct of studies including sample bundling and shipping process
  • Review all hard copy source data and Biznet electronic source data related to all protocol and SOP driven parameters
  • Review the Trial Master File and Pharmacy binders, Crash Carts logs to ensure are in accordance with protocol and SOP requirements
  • Perform system audits as required
  • Interact on daily basis with relevant team members to improve the accuracy and quality of data.
  • Provide reports of the reviewed data to relevant personnel/department
  • Perform other duties as assigned by supervisor
POSITION REQUIREMENTS:
  • A minimum of a post-secondary degree or diploma in a sciences or healthcare related discipline.
  • Knowledge of research principles, ICH/GCP guidelines and applicable regulations
  • Demonstrated experience with MS office (Word, Excel, Outlook, PowerPoint)
  • Excellent interpersonal, verbal and written communication skills
  • Ability to work effectively and efficiently in a fast paced, multitasking environment
  • Detail oriented with effective decision making and problem solving skills
  • Ability to work flexible hours both day and evening shifts including weekends and evenings.
 

Previous Experience:

  • 1-2 years previous clinical research experience in CRO/pharmaceutical industry is preferable.