Clinical Research Associate

1 week ago

Richmond British Columbia, Greater Vancouver, Canada Goldbeck Recruiting Full time

Our client is a privately owned Canadian company that is focused on the research, development and commercialization of medical diagnostics using their proprietary technology platform. They have won several local and industry awards. They are looking for a Clinical Research Associate to work out of their state-of-the-art facility in Richmond. They are true to their core values and are passionate and motivated about what they do.


Responsibilities:

  • Demonstrate and integrate bioLytical product knowledge to design, create and write trial protocols and study documentation including ethics applications for bioLytical products and liaising with regulatory authorities.
  • Conduct data analysis, compile and generate scientific reports, regulatory documentation, and research-related documents.
  • Ensure study sites and activities adhere to appropriate industry protocols and terms of study.
  • Train and oversee site staff on bioLytical product tests, therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
  • Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
  • Conduct and document study monitoring/site visits, coordinate project meetings and implement actions for sites do not meeting expectations.
  • Order, track, and manage clinical and trial materials.
  • Oversee and document investigational product dispensing inventory, and reconciliation
  • Protect subjects’ confidentiality, update information, and verify IP have been dispensed and administered according to protocol.
  • Oversee study database design and management.
  • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.


Qualifications:

  • Bachelor’s degree in Biological Science or a related field.
  • Minimum 3 years of experience in clinical operations.
  • Knowledge of the diagnostics industry, terminology, and practices and FDA regulations and their practical implementation.
  • Strong background in statistical data collection, validation, editing and analysis techniques.
  • Superior problem solving, deductive reasoning and decision-making skills.
  • Strong verbal and written communication skills.
  • Proficient computer skills, with Microsoft Office Word, Excel, and PowerPoint.
  • Good time management and ability to prioritize task and accomplish set goals efficiently.
  • Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies will be an asset

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