Toronto, Ontario – Quality Control Reviewer

Reports to:  Supervisor Quality Control

 

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. Other responsibilities as assigned.

 

Duties and 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, SOPs and regulations
  • Review all other study related documentation: medical screening files, pharmacy labels and files
  • Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
  • Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
  • Provide reports of the reviewed data to relevant personnel/department
  • Performs other tasks and projects as assigned
  • Develop and utilize QC Checklist or other QC tools designed to document the QC review process
  • Assist with training of new QC Data Reviewer Staff
  • Participate in review of SOP’s and Protocols
  • Ensure the conduct of clinical trial according the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Biopharma Services Inc SOP’s at all times (copied from CRC’s responsibility)

 

Qualifications:

  • Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
  • Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
  • Excellent communication skills
  • Excellent computer skills
  • Certification in Clinical Research is an asset.

Please send your resume to resumes@biopharmaservices.com