Clinical Quality Control Associate II

CareAboutMontreal, QC
Onsite

About The Position

The Clinical Quality Control Associate is responsible for the quality control (QC) review of clinical trial data and working with the Quality Systems team to complete QC related tasks. The Clinical Quality Control Associate will conduct tasks performed within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

Requirements

  • High School Diploma completed.
  • Good Communication in French and English.
  • Detail oriented, well organized, customer service focused, able to work in fast-paced environment.
  • Software: Microsoft Office.
  • Strong attention to details
  • Personal/professional integrity and proven discretion in handling confidential information.
  • Ability to develop strong trusting relationships in order to gain support and achieve results.
  • Capable of managing multiple conflicting priorities.
  • Must be self-directed, motivated and have a willingness to take initiative.
  • The candidate must be able to lift up to 25 pounds.
  • Fluency in English is an essential requirement for the position of Clinical Quality Control Associate including, but not limited to, for the following reasons: The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

Nice To Haves

  • College degree and related work experience an asset
  • Related work experience an asset.

Responsibilities

  • Ensure the confidentiality of clinical trial participants and sponsors is respected.
  • Maintain and advocate a high level of quality and customer service within the department.
  • Record, track and ensure the resolution of data queries.
  • Act as a mentor and coach the Quality Systems team members.
  • May document and/or report clinical trial related deviations (i.e. SOP, protocol).
  • Report, track and escalate (if necessary) errors and/or trends that may require re-training, as required by location.
  • Compile data and maintain computerized files and/or update deviation tracking systems.
  • Understand protocol driven timed study events and acceptable collection windows (protocol and/or SOP driven) for the timed events.
  • Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
  • Other tasks as assigned by management

Benefits

  • Health/dental/vision insurance plans
  • RRSP with employer match
  • Paid vacation and statutory vacations
  • Paid sick leave and bereavement leave
  • Employee assistance and telehealth programs
  • Training and development programs
  • Employee orientation bonus program
  • Annual performance reviews
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